The following data is part of a premarket notification filed by Wolfe Tory Medical, Inc. with the FDA for Esophageal Intubation Detector Adapter - (eid-adapter).
| Device ID | K945745 |
| 510k Number | K945745 |
| Device Name: | ESOPHAGEAL INTUBATION DETECTOR ADAPTER - (EID-ADAPTER) |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WOLFE TORY MEDICAL, INC. 4425 S. 500 W.,STE. F Salt Lake City, UT 84123 |
| Contact | Tim Wolfe |
| Correspondent | Tim Wolfe WOLFE TORY MEDICAL, INC. 4425 S. 500 W.,STE. F Salt Lake City, UT 84123 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-23 |
| Decision Date | 1994-12-07 |