The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Neuro Endoscope (model 2230).
Device ID | K941188 |
510k Number | K941188 |
Device Name: | CLARUS NEURO ENDOSCOPE (MODEL 2230) |
Classification | Arthroscope |
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 | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-14 |
Decision Date | 1995-04-25 |