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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B7837064001 | K003332 | 000 |
| B783706400170601160 | K003332 | 000 |
| B783706400170601171 | K003332 | 000 |
| B783706400170601130 | K003332 | 000 |
| B783704500170501138 | K003332 | 000 |
| B783706400170601172 | K003332 | 000 |
| B783704500170601129 | K003332 | 000 |
| B783706400170601174 | K003332 | 000 |
| B783704500170601177 | K003332 | 000 |
| B7837045001705011237 | K003332 | 000 |
| B783704500170501136 | K003332 | 000 |
| B7837045001705011226 | K003332 | 000 |
| B7837045001705011327 | K003332 | 000 |
| B7837045001 | K003332 | 000 |
| B783706400170601127 | K003332 | 000 |