K761308 is an FDA 510(k) clearance for the ELECTRONIC STETHOSCOPE. This device is classified as a Radioimmunoassay, Digoxin (3-h), Rabbit Antibody, Charcoal Sep. (Class II - Special Controls, product code DPD).
Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 6, 1977, 14 days after receiving the submission on December 23, 1976.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K761308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1976 |
| Decision Date | January 06, 1977 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | DPD — Radioimmunoassay, Digoxin (3-h), Rabbit Antibody, Charcoal Sep. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |