The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Model 2127-900 Series Endoscope Adater (2127-900 Series).
| Device ID | K971584 |
| 510k Number | K971584 |
| Device Name: | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) |
| Classification | Endoscope Holder |
| 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 | OCV |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-30 |
| Decision Date | 1997-05-23 |
| Summary: | summary |