K761194 is an FDA 510(k) clearance for the HLR QUICK-FIT HEART-LUNG RESUSCITATOR. This device is classified as a Compressor, Cardiac, External (Class II - Special Controls, product code DRM).
Submitted by Mckesson Corp. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1976, 3 days after receiving the submission on December 6, 1976.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5200.
| 510(k) Number | K761194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1976 |
| Decision Date | December 09, 1976 |
| Days to Decision | 3 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRM — Compressor, Cardiac, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5200 |