The following data is part of a premarket notification filed by Honeywell, Inc. with the FDA for Thermograph, Medical.
Device ID | K760999 |
510k Number | K760999 |
Device Name: | THERMOGRAPH, MEDICAL |
Classification | System, Telethermographic, Infrared |
Applicant | HONEYWELL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYM |
CFR Regulation Number | 884.2980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-08 |
Decision Date | 1976-11-19 |