The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Murphypen Endoscope(2127-xxx).
| Device ID | K962255 |
| 510k Number | K962255 |
| Device Name: | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Contact | John Vanden Hoek |
| Correspondent | John Vanden Hoek CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-09-11 |
| Summary: | summary |