K943495 is an FDA 510(k) clearance for the DISPOSABLE ESOPHAGEAL STETHOSCOPE. This device is classified as a Stethoscope, Esophageal, With Electrical Conductors (Class II - Special Controls, product code BZT).
Submitted by Coast Medical, Inc. (Orange, US). The FDA issued a Cleared decision on September 8, 1994, 51 days after receiving the submission on July 19, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1920.
| 510(k) Number | K943495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1994 |
| Decision Date | September 08, 1994 |
| Days to Decision | 51 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BZT — Stethoscope, Esophageal, With Electrical Conductors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1920 |