M-SCAN
Device, Muscle Monitoring
BIO-RESEARCH ASSOCIATES, INC.
The following data is part of a premarket notification filed by Bio-research Associates, Inc. with the FDA for M-scan.
Pre-market Notification Details
| Device ID | K130158 |
| 510k Number | K130158 |
| Device Name: | M-SCAN |
| Classification | Device, Muscle Monitoring |
| Applicant | BIO-RESEARCH ASSOCIATES, INC. 4555 W Schroeder Dr Ste 100 Brown Deer, WI 53223 |
| Contact | John Radke |
| Correspondent | John Radke BIO-RESEARCH ASSOCIATES, INC. 4555 W Schroeder Dr Ste 100 Brown Deer, WI 53223 |
| Product Code | KZM |
| CFR Regulation Number | 890.1375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-23 |
| Decision Date | 2013-07-25 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003499962 | K130158 | 000 |
| 00860003499955 | K130158 | 000 |
Trademark Results [M-SCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M-SCAN 78917824 not registered Dead/Abandoned |
SynergEyes, Inc. 2006-06-27 |
 M-SCAN 78874820 3655977 Dead/Cancelled |
M-Scan Limited 2006-05-02 |
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