The following data is part of a premarket notification filed by Wolfe-carney Medical with the FDA for Esophageal Intubation Detector.
| Device ID | K930741 |
| 510k Number | K930741 |
| Device Name: | ESOPHAGEAL INTUBATION DETECTOR |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WOLFE-CARNEY MEDICAL 1119 E. ALPINE PL. Salt Lake City, UT 84105 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1993-08-07 |