K945745 is an FDA 510(k) clearance for the ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER). This device is classified as a Tube, Tracheal (w/wo Connector) (Class II - Special Controls, product code BTR).
Submitted by Wolfe Tory Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 7, 1994, 14 days after receiving the submission on November 23, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5730.
| 510(k) Number | K945745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1994 |
| Decision Date | December 07, 1994 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BTR — Tube, Tracheal (w/wo Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5730 |