Submission Details
| 510(k) Number | K963848 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 1996 |
| Decision Date | July 07, 1997 |
| Days to Decision | 285 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
Cleared
Traditional
K963848 - MANUAL RESUSCITATOR
(FDA 510(k) Clearance)
Jul 1997
Decision
285d
Days
Class 2
Risk
K963848 is an FDA 510(k) clearance for the MANUAL RESUSCITATOR. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM).
Submitted by Owens-Brigam Medical Co. (Newland, US). The FDA issued a Cleared decision on July 7, 1997, 285 days after receiving the submission on September 25, 1996.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
Device Classification
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.5915 |
Similar Devices — BTM Ventilator, Emergency, Manual (resuscitator)
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