The following data is part of a premarket notification filed by Urohealth, Inc. with the FDA for Integrated Visualization System.
| Device ID | K970598 |
| 510k Number | K970598 |
| Device Name: | INTEGRATED VISUALIZATION SYSTEM |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | UROHEALTH, INC. 3050 REDHILL AVE. Costa Mesa, CA 92626 |
| Contact | Ronald Bergeson |
| Correspondent | Ronald Bergeson UROHEALTH, INC. 3050 REDHILL AVE. Costa Mesa, CA 92626 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-03-12 |
| Summary: | summary |