The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Lf-1 Intubation Scope.
| Device ID | K850978 |
| 510k Number | K850978 |
| Device Name: | OLYMPUS LF-1 INTUBATION SCOPE |
| Classification | Laryngoscope, Non-rigid |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Terry J Hartl |
| Correspondent | Terry J Hartl OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | CAL |
| CFR Regulation Number | 868.5530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-08 |
| Decision Date | 1985-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170051098 | K850978 | 000 |