The following data is part of a premarket notification filed by Meditherm, Inc. with the FDA for Meditherm Med2000.
Device ID | K003332 |
510k Number | K003332 |
Device Name: | MEDITHERM MED2000 |
Classification | System, Telethermographic (adjunctive Use) |
Applicant | MEDITHERM, INC. 7407 DOVER LN. Parkland, FL 33067 |
Contact | Peter Leando |
Correspondent | Peter Leando MEDITHERM, INC. 7407 DOVER LN. Parkland, FL 33067 |
Product Code | LHQ |
CFR Regulation Number | 884.2980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-24 |
Decision Date | 2001-02-21 |