K945082 is an FDA 510(k) clearance for the CYPRESS MEDICAL PRODUCTS STETHOSCOPE. This device is classified as a Stethoscope, Manual (Class I - General Controls, product code LDE).
Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on December 8, 1994, 52 days after receiving the submission on October 17, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1875.
| 510(k) Number | K945082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 1994 |
| Decision Date | December 08, 1994 |
| Days to Decision | 52 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 |