The following data is part of a premarket notification filed by Kirk Specialty Systems with the FDA for Esophageal Intubation Detector.
| Device ID | K962098 |
| 510k Number | K962098 |
| Device Name: | ESOPHAGEAL INTUBATION DETECTOR |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | KIRK SPECIALTY SYSTEMS 1625 CRESCENT CIR., STE. 225 Carrollton, TX 75006 |
| Contact | Dale B Ickley |
| Correspondent | Dale B Ickley KIRK SPECIALTY SYSTEMS 1625 CRESCENT CIR., STE. 225 Carrollton, TX 75006 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-29 |
| Decision Date | 1996-10-08 |