The following data is part of a premarket notification filed by Nicolet Biomedical, Inc. with the FDA for Biorehab System.
Device ID | K011823 |
510k Number | K011823 |
Device Name: | BIOREHAB SYSTEM |
Classification | Device, Biofeedback |
Applicant | NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
Contact | Gary J Syring |
Correspondent | Gary J Syring NICOLET BIOMEDICAL, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
Product Code | HCC |
CFR Regulation Number | 882.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-06-11 |
Decision Date | 2001-09-06 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIOREHAB SYSTEM 75875470 2525896 Dead/Cancelled |
Enhanced Mobility Technologies, Inc. 2000-01-03 |