510(k) K963848
K963848 is an FDA 510(k) premarket notification submitted by Owens-Brigam Medical Co. for the device "MANUAL RESUSCITATOR". The FDA issued a decision of Substantially Equivalent on July 7, 1997. The device falls under product code BTM (Ventilator, Emergency, Manual (Resuscitator)), a Class II device regulated under 21 CFR 868.5915. Owens-Brigam Medical Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 1997
- Date Received
- September 25, 1996
- 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