The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Neuro Channel Endoscope Model 2232.
| Device ID | K945633 |
| 510k Number | K945633 |
| Device Name: | NEURO CHANNEL ENDOSCOPE MODEL 2232 |
| Classification | Endoscope, Neurological |
| Applicant | CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Contact | John V Hoek |
| Correspondent | John V Hoek CLARUS MEDICAL SYSTEMS, INC. 1000 BOONE AVENUE NORTH #100 Minneapolis, MN 55427 -8656 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-16 |
| Decision Date | 1995-09-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169498051 | K945633 | 000 |
| 00810004820654 | K945633 | 000 |
| 00810004820661 | K945633 | 000 |
| 00643169497672 | K945633 | 000 |
| 00643169497689 | K945633 | 000 |
| 00643169497696 | K945633 | 000 |
| 00643169497702 | K945633 | 000 |
| 00643169497719 | K945633 | 000 |
| 00643169497726 | K945633 | 000 |
| 00643169497733 | K945633 | 000 |
| 00643169497740 | K945633 | 000 |
| 00643169497757 | K945633 | 000 |
| 00643169498037 | K945633 | 000 |
| 00643169498044 | K945633 | 000 |
| 00810004820937 | K945633 | 000 |