The following data is part of a premarket notification filed by Em Diagnostics, Inc. with the FDA for Emd Thermography System.
| Device ID | K050239 |
| 510k Number | K050239 |
| Device Name: | EMD THERMOGRAPHY SYSTEM |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | EM DIAGNOSTICS, INC. 1151 HOPE STREET Stamford, CT 06907 |
| Contact | Richard Keen |
| Correspondent | Richard Keen EM DIAGNOSTICS, INC. 1151 HOPE STREET Stamford, CT 06907 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-02 |
| Decision Date | 2006-03-16 |
| Summary: | summary |