The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Flexible Fiber-optic Nasopharyngoscope.
| Device ID | K895245 |
| 510k Number | K895245 |
| Device Name: | FLEXIBLE FIBER-OPTIC NASOPHARYNGOSCOPE |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
| Contact | Ehmsen, Scd |
| Correspondent | Ehmsen, Scd OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-21 |
| Decision Date | 1989-11-17 |