Infrascanner
Infrared Hematoma Detector
InfraScan, Inc.
The following data is part of a premarket notification filed by Infrascan, Inc. with the FDA for Infrascanner.
Pre-market Notification Details
| Device ID | K200203 |
| 510k Number | K200203 |
| Device Name: | Infrascanner |
| Classification | Infrared Hematoma Detector |
| Applicant | InfraScan, Inc. 3508 Market Street Philadelphia, PA 19104 |
| Contact | Baruch Ben Dor |
| Correspondent | Angela Mallery NAMSA 400 US-169 Minneapolis, MN 55441 |
| Product Code | OPT |
| CFR Regulation Number | 882.1935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-28 |
| Decision Date | 2020-07-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861606000326 | K200203 | 000 |
Trademark Results [Infrascanner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INFRASCANNER 85767823 4357918 Live/Registered |
InfraScan, Inc. 2012-10-31 |
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