The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Phoenix Neuro Endoscope Model 2160.
Device ID | K945296 |
510k Number | K945296 |
Device Name: | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 |
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 | 1994-10-31 |
Decision Date | 1995-07-14 |