The following data is part of a premarket notification filed by Prizm Medical, Inc. with the FDA for Prizm Medical Inc. Thermotrace Infrared Thermometer Models 15004 And 15007.
| Device ID | K012974 |
| 510k Number | K012974 |
| Device Name: | PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | PRIZM MEDICAL, INC. 5536 TROWBRIDGE DR. Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria PRIZM MEDICAL, INC. 5536 TROWBRIDGE DR. Dunwoody, GA 30338 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-05 |
| Decision Date | 2002-07-23 |
| Summary: | summary |