K923327 is an FDA 510(k) clearance for the STETHOSCOPE COVER. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).
Submitted by Anup Chakraborty Co. (Lincoln, US). The FDA issued a Cleared decision on November 3, 1992, 119 days after receiving the submission on July 7, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K923327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1992 |
| Decision Date | November 03, 1992 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | LDE — Stethoscope, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.1875 |