The following data is part of a premarket notification filed by Infrascan, Inc. with the FDA for Infrascanner.
Device ID | K211617 |
510k Number | K211617 |
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 | 2021-05-26 |
Decision Date | 2022-02-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() INFRASCANNER 85767823 4357918 Live/Registered |
InfraScan, Inc. 2012-10-31 |