Substantial equivalence

Remsleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Retrieved on: 
Monday, January 22, 2024
Frustration, Substantial equivalence, Obstructive sleep apnea, OTCQB, CPAP, OSA, Life, FDA, Medical device

The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and Performance testing.

Key Points: 
  • The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and Performance testing.
  • All these questions can be answered, and we are in the process of responding with the answers.
  • Remsleep CEO, Tom Wood, commented: “Investors want a 510(K) almost as much as Remsleep.
  • Remsleep received feedback from FDA with a request for additional information.

Incheon Songdo Becomes One-Stop MICE Service With International Conference Complex Zone

Retrieved on: 
Monday, January 9, 2023
Transport, Ecosystem, Art Center, Economic development, Internet, Incheon International Airport, Substantial equivalence, ROMI, IOT, Environment, Tourism, Conference, City, Policy, Growth, KIOSK, Patient, Atmosphere, Emergency medical services, MICE, Sheraton Grand Incheon Hotel, Disaster, Hotel

In particular, along with the completion of Incheon Songdo International Conference Complex Zone (ICCZ), Incheon is strengthening its position as a core city of the MICE (Meeting Incentives Convention Exhibition) industry.

Key Points: 
  • In particular, along with the completion of Incheon Songdo International Conference Complex Zone (ICCZ), Incheon is strengthening its position as a core city of the MICE (Meeting Incentives Convention Exhibition) industry.
  • Incheon has secured a traffic network in all directions, such as the Incheon Port, the Incheon subway line, and the Incheon International Airport.
  • In 2018, Incheon established the Five-Year Plan for fostering and promoting the Incheon Songdo International Conference Complex Zone.
  • Accommodation, shopping, and cultural facilities are concentrated around Songdo Convensia, providing one-stop service to international conference participants.

Xcaliber International Receives SE Orders from The FDA

Retrieved on: 
Tuesday, May 15, 2018
Health, Food safety, Biotechnology, Food and Drug Administration, United States Public Health Service, Food and drink, Substantial equivalence, Four Loko, Public health

"Xcaliber is among the first 4th Tier manufacturers to receive substantial equivalence orders," said Chief Operating Officer Derrick Taylor.

Key Points: 
  • "Xcaliber is among the first 4th Tier manufacturers to receive substantial equivalence orders," said Chief Operating Officer Derrick Taylor.
  • "With these orders, Xcaliber is poised to better serve its wholesale and retail partners in the 40-plus states in which we operate," Taylor continued.
  • The orders issued by the FDA provide Xcaliber with certainty," explained Eric Estes, General Counsel.
  • "The issued SE orders are representative of many of our brands and Xcaliber looks forward to working with the FDA to achieve substantial equivalence on all of our products," Estes continued.