The following data is part of a premarket notification filed by Sunmed, Inc. with the FDA for Sunlite Laryngoscope.
| Device ID | K921263 |
| 510k Number | K921263 |
| Device Name: | SUNLITE LARYNGOSCOPE |
| Classification | Laryngoscope, Rigid |
| Applicant | SUNMED, INC. 5401 TECH DATA DR. Clearwater, FL 34620 |
| Contact | George Cranton |
| Correspondent | George Cranton SUNMED, INC. 5401 TECH DATA DR. Clearwater, FL 34620 |
| Product Code | CCW |
| CFR Regulation Number | 868.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-16 |
| Decision Date | 1993-06-01 |