The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Optosafe.
| Device ID | K960240 |
| 510k Number | K960240 |
| Device Name: | RUSCH OPTOSAFE |
| Classification | Airway, Oropharyngeal, Anesthesiology |
| Applicant | RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Contact | Neil R Armstrong |
| Correspondent | Neil R Armstrong RUSCH INTL. TALL PINES PARK Jaffrey, NH 03452 |
| Product Code | CAE |
| CFR Regulation Number | 868.5110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-16 |
| Decision Date | 1996-04-19 |
| Summary: | summary |