The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Model 5197 Sightlite.
| Device ID | K971455 |
| 510k Number | K971455 |
| Device Name: | CLARUS MODEL 5197 SIGHTLITE |
| Classification | Lamp, Endoscope, Incandescent |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Contact | Dale Sappenfield |
| Correspondent | Dale Sappenfield CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Product Code | FTI |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-21 |
| Decision Date | 1997-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B06751972010 | K971455 | 000 |