The following data is part of a premarket notification filed by Olive Medical Corp. with the FDA for Ovs1 Video System.
| Device ID | K123359 |
| 510k Number | K123359 |
| Device Name: | OVS1 VIDEO SYSTEM |
| Classification | Light Source, Fiberoptic, Routine |
| Applicant | OLIVE MEDICAL CORP. 2302 Presidents Dr Ste D Salt Lake City, UT 84120 |
| Contact | Brian Dean |
| Correspondent | Brian Dean OLIVE MEDICAL CORP. 2302 Presidents Dr Ste D Salt Lake City, UT 84120 |
| Product Code | FCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2012-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886705028702 | K123359 | 000 |