The following data is part of a premarket notification filed by Opticon Medical, Inc. with the FDA for Weingarten Tm Capnographic Intubation Stylette.
| Device ID | K904999 |
| 510k Number | K904999 |
| Device Name: | WEINGARTEN TM CAPNOGRAPHIC INTUBATION STYLETTE |
| Classification | Stylet, Tracheal Tube |
| Applicant | OPTICON MEDICAL, INC. 806 BRIAN COURT Gurnee, IL 60031 |
| Contact | Jane Patrick |
| Correspondent | Jane Patrick OPTICON MEDICAL, INC. 806 BRIAN COURT Gurnee, IL 60031 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-06 |
| Decision Date | 1993-01-26 |