The following data is part of a premarket notification filed by Inframetrics, Inc. with the FDA for Inframetrics Infracam-med.
| Device ID | K982327 |
| 510k Number | K982327 |
| Device Name: | INFRAMETRICS INFRACAM-MED |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | INFRAMETRICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara-cullinane |
| Correspondent | Mary Mcnamara-cullinane INFRAMETRICS, INC. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1998-08-18 |
| Summary: | summary |