K930429 is an FDA 510(k) clearance for the AID, CARDIOPULMONARY RESUSCITATION. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on March 11, 1993, 44 days after receiving the submission on January 26, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K930429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1993 |
| Decision Date | March 11, 1993 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |