The following data is part of a premarket notification filed by Wolfe Tory Medical, Inc. with the FDA for Esophageal Intubation Detector Bulb.
| Device ID | K942628 |
| 510k Number | K942628 |
| Device Name: | ESOPHAGEAL INTUBATION DETECTOR BULB |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WOLFE TORY MEDICAL, INC. P.O. BOX 526437 Salt Lake City, UT 84152 |
| Contact | Timothy R Wolfe |
| Correspondent | Timothy R Wolfe WOLFE TORY MEDICAL, INC. P.O. BOX 526437 Salt Lake City, UT 84152 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-02 |
| Decision Date | 1994-08-18 |