The following data is part of a premarket notification filed by Alfa Thermodiagnostics, Inc. with the FDA for Alfasight 9000 Thermographic System.
| Device ID | K150457 |
| 510k Number | K150457 |
| Device Name: | AlfaSight 9000 Thermographic System |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | ALFA THERMODIAGNOSTICS, INC. 9057 SOQUEL DRIVE, STE B-AA Aptos, CA 95033 |
| Contact | Daniel Beilin |
| Correspondent | John J Smith HOGAN LOVELLS US LLP 555 THIRTEENTH 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 | 2015-02-20 |
| Decision Date | 2015-04-10 |
| Summary: | summary |