Masimo Receives FDA Clearance for Stork™ Over-the-Counter (OTC) Baby Monitoring System
Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork App, in an update scheduled to be released this summer.
- Alongside the FDA clearance, Masimo will make Stork’s new alarm features available to all existing and new Stork users through the Masimo Stork App, in an update scheduled to be released this summer.
- Masimo Stork is 510(k) cleared for OTC use as a wearable device intended for the monitoring of multiple physiological parameters.
- Masimo Stork is not intended to replace the monitoring, diagnosis, or treatment provided by a physician or healthcare provider.
- Masimo Stork is not intended for use with infants and neonates previously diagnosed with cardiovascular or respiratory disease or conditions.