K902733 is an FDA 510(k) clearance for the 1ST RESPONSE (TM) INFANT MANUAL RESUSCITATOR. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on August 22, 1990, 62 days after receiving the submission on June 21, 1990.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K902733 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 1990 |
| Decision Date | August 22, 1990 |
| Days to Decision | 62 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |