The following data is part of a premarket notification filed by Upsher Laryngoscope Co. with the FDA for Upsherscope(tm).
| Device ID | K922275 |
| 510k Number | K922275 |
| Device Name: | UPSHERSCOPE(TM) |
| Classification | Laryngoscope, Rigid |
| Applicant | UPSHER LARYNGOSCOPE CO. 1155C CHESS DRIVE, SUITE A P.O. BOX 4519 Foster City, CA 94404 |
| Contact | Michael Upsher |
| Correspondent | Michael Upsher UPSHER LARYNGOSCOPE CO. 1155C CHESS DRIVE, SUITE A P.O. BOX 4519 Foster City, CA 94404 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-14 |
| Decision Date | 1993-01-06 |