K953793 is an FDA 510(k) clearance for the INTROSCOPE. This device is classified as a Stethoscope, Esophageal, With Electrical Conductors (Class II - Special Controls, product code BZT).
Submitted by Polamedco, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on November 29, 1995, 107 days after receiving the submission on August 14, 1995.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1920.
| 510(k) Number | K953793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 1995 |
| Decision Date | November 29, 1995 |
| Days to Decision | 107 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 |