The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Neuropen Model 2120.
| Device ID | K942249 |
| 510k Number | K942249 |
| Device Name: | CLARUS NEUROPEN MODEL 2120 |
| 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 | 1994-05-09 |
| Decision Date | 1994-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0673000N0 | K942249 | 000 |
| B0673000C0 | K942249 | 000 |
| B0672120C1 | K942249 | 000 |
| 00810004820678 | K942249 | 000 |