K862672 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPE WITH THERMISTOR. This device is classified as a Stethoscope, Esophageal, With Electrical Conductors (Class II - Special Controls, product code BZT).
Submitted by Inmed Corp. (Norcross, US). The FDA issued a Cleared decision on October 27, 1986, 105 days after receiving the submission on July 14, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1920.
| 510(k) Number | K862672 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 1986 |
| Decision Date | October 27, 1986 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BZT — Stethoscope, Esophageal, With Electrical Conductors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1920 |