The following data is part of a premarket notification filed by Optimed Technologies, Inc. with the FDA for Fiberoptic Catheter.
| Device ID | K880661 |
| 510k Number | K880661 |
| Device Name: | FIBEROPTIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
| Contact | Ronald J Ehmsen,scd |
| Correspondent | Ronald J Ehmsen,scd OPTIMED TECHNOLOGIES, INC. 17991 FITCH Irvine, CA 92714 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-17 |
| Decision Date | 1988-05-02 |