The following data is part of a premarket notification filed by Gst Laboratories Of Ca, Inc. with the FDA for Graphic Stress Telethermometry.
Device ID | K800491 |
510k Number | K800491 |
Device Name: | GRAPHIC STRESS TELETHERMOMETRY |
Classification | System, Telethermographic, Infrared |
Applicant | GST LABORATORIES OF CA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IYM |
CFR Regulation Number | 884.2980 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-04 |
Decision Date | 1980-03-04 |