The following data is part of a premarket notification filed by Ovamed Corp. with the FDA for Saratoga Modular Miniature Endoscope System.
| Device ID | K943593 |
| 510k Number | K943593 |
| Device Name: | SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEM |
| Classification | Mini Endoscope, Gastroenterology-urology |
| Applicant | OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
| Contact | John Zink |
| Correspondent | John Zink OVAMED CORP. 111 WEST EVELYN AVENUE, SUITE 214 Sunnyvale, CA 94086 |
| Product Code | ODF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-25 |
| Decision Date | 1995-03-22 |