The following data is part of a premarket notification filed by Wolfe Tory Medical, Inc. with the FDA for Esophageal Intubation Detector.
| Device ID | K990556 |
| 510k Number | K990556 |
| Device Name: | ESOPHAGEAL INTUBATION DETECTOR |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 21 Salt Lake City, UT 84107 |
| Contact | Tim Wolfe |
| Correspondent | Tim Wolfe WOLFE TORY MEDICAL, INC. 79 WEST 4500 SOUTH, SUITE 21 Salt Lake City, UT 84107 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-22 |
| Decision Date | 1999-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 25060112313299 | K990556 | 000 |
| 25060112313282 | K990556 | 000 |