The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Hysteroscope (and Accessories).
| Device ID | K921942 |
| 510k Number | K921942 |
| Device Name: | HYSTEROSCOPE (AND ACCESSORIES) |
| Classification | Hysteroscope (and Accessories) |
| Applicant | OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
| Product Code | HIH |
| CFR Regulation Number | 884.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-24 |
| Decision Date | 1994-06-24 |