510(k) K211387
K211387 is an FDA 510(k) premarket notification submitted by Sound Life Sciences, Inc. for the device "Breathe Easy Mobile Respiratory Monitor (MRM)". The FDA issued a decision of Substantially Equivalent on November 23, 2021. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 2021
- Date Received
- May 5, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type