The following data is part of a premarket notification filed by First Sense Medical, Llc with the FDA for Firstsense Breast Exam.
Device ID | K160573 |
510k Number | K160573 |
Device Name: | FirstSense Breast Exam |
Classification | System, Telethermographic (adjunctive Use) |
Applicant | First Sense Medical, LLC 2001 Centerpoint Parkways, Suite 110 Pontiac, MI 48341 |
Contact | Paul G. Angott |
Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street, NW Washington, DC 20004 |
Product Code | LHQ |
CFR Regulation Number | 884.2980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-29 |
Decision Date | 2016-06-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FIRSTSENSE BREAST EXAM 85722070 4556603 Live/Registered |
FIRST SENSE MEDICAL, LLC 2012-09-06 |