510(k) K161953
K161953 is an FDA 510(k) premarket notification submitted by Tereopneuma for the device "ReDe Mask". The FDA issued a decision of Substantially Equivalent on February 17, 2017. The device falls under product code PRK (Device Indicating An Exhalation Event), a Class II device regulated under 21 CFR 868.2375.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2017
- Date Received
- July 18, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device Indicating An Exhalation Event
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type
To provide visual indication of each exhalation event