K860558 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE. This device is classified as a Stethoscope, Esophageal (Class I - General Controls, product code BZW).
Submitted by Sharn, Inc. (Tampa, US). The FDA issued a Cleared decision on April 1, 1986, 46 days after receiving the submission on February 14, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1910.
| 510(k) Number | K860558 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1986 |
| Decision Date | April 01, 1986 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZW — Stethoscope, Esophageal |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.1910 |