Ox-Imager CS
Oximeter, Tissue Saturation
MODULATED IMAGING, INC.
The following data is part of a premarket notification filed by Modulated Imaging, Inc. with the FDA for Ox-imager Cs.
Pre-market Notification Details
| Device ID | K153426 |
| 510k Number | K153426 |
| Device Name: | Ox-Imager CS |
| Classification | Oximeter, Tissue Saturation |
| Applicant | MODULATED IMAGING, INC. 17151 GILLETTE AVE Irvine, CA 92604 |
| Contact | David Cuccia |
| Correspondent | Maureen O'connell O'CONNELL REGULATORY CONSULTANTS, INC. 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-25 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859806007016 | K153426 | 000 |
Trademark Results [Ox-Imager CS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OX-IMAGER CS 87590421 5504825 Live/Registered |
Modulated Imaging, Inc. 2017-08-30 |
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