K800463 is an FDA 510(k) clearance for the ESOPHAGEAL STETHESCOPE. This device is classified as a Stethoscope, Esophageal (Class I - General Controls, product code BZW).
Submitted by Medical Components, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1980, 10 days after receiving the submission on February 29, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1910.
| 510(k) Number | K800463 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 1980 |
| Decision Date | March 10, 1980 |
| Days to Decision | 10 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 |