The following data is part of a premarket notification filed by Optus, Inc. with the FDA for Optus Laryngoscopes.
| Device ID | K945269 |
| 510k Number | K945269 |
| Device Name: | OPTUS LARYNGOSCOPES |
| Classification | Laryngoscope, Rigid |
| Applicant | OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Contact | Peter Duffy |
| Correspondent | Peter Duffy OPTUS, INC. 1200 SOUTH PARKER RD. Denver, CO 80231 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1994-11-07 |