The following data is part of a premarket notification filed by Novarad Corporation with the FDA for Visar.
Device ID | K220146 |
510k Number | K220146 |
Device Name: | VisAR |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604 |
Contact | Doug Merrill |
Correspondent | Doug Merrill Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604 |
Product Code | OLO |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-19 |
Decision Date | 2022-05-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B109VISAR2150 | K220146 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VISAR 98110937 not registered Live/Pending |
Thermoteknix Systems Ltd. 2023-08-01 |
VISAR 90856881 not registered Live/Pending |
Novarad Corporation 2021-07-29 |
VISAR 85732277 4524198 Live/Registered |
TSG Solutions, Inc. 2012-09-18 |
VISAR 74374730 1858134 Dead/Cancelled |
Motorola Inc. 1993-04-02 |