510(k) K881686
K881686 is an FDA 510(k) premarket notification submitted by Devolve Corp. for the device "CPR BAG". The FDA issued a decision of Substantially Equivalent on Jun 23, 1988. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 23, 1988
- Date Received
- Apr 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Ventilator, Emergency, Manual (Resuscitator)
- Device Class
- Class II
- Regulation Number
- 868.5915
- Review Panel
- AN
- Submission Type
- 510(k)