The following data is part of a premarket notification filed by Gst Laboratories Of Ca, Inc. with the FDA for Gst System Thermographic Application.
| Device ID | K842878 |
| 510k Number | K842878 |
| Device Name: | GST SYSTEM THERMOGRAPHIC APPLICATION |
| Classification | System, Telethermographic (adjunctive Use) |
| Applicant | GST LABORATORIES OF CA, INC. BURDITT, BOWLES & RADZIUS 135 SOUTH LA SALLE STREET Chicago , IL 60603 - |
| Contact | Joseph R Radzius |
| Correspondent | Joseph R Radzius GST LABORATORIES OF CA, INC. BURDITT, BOWLES & RADZIUS 135 SOUTH LA SALLE STREET Chicago , IL 60603 - |
| Product Code | LHQ |
| CFR Regulation Number | 884.2980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-23 |
| Decision Date | 1985-03-22 |