K843071 is an FDA 510(k) clearance for the ESOPHAGEAL STETHOSCOPES W/ELEC CONDUCTOR. This device is classified as a Stethoscope, Esophageal, With Electrical Conductors (Class II - Special Controls, product code BZT).
Submitted by Primrose Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1984, 18 days after receiving the submission on August 6, 1984.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1920.
| 510(k) Number | K843071 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1984 |
| Decision Date | August 24, 1984 |
| Days to Decision | 18 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 |