510(k) K842878

GST SYSTEM THERMOGRAPHIC APPLICATION by Gst Laboratories of Ca, Inc. — Product Code LHQ

K842878 is an FDA 510(k) premarket notification submitted by Gst Laboratories of Ca, Inc. for the device "GST SYSTEM THERMOGRAPHIC APPLICATION". The FDA issued a decision of Substantially Equivalent on March 22, 1985. The device falls under product code LHQ (System, Telethermographic (Adjunctive Use)), a Class I device regulated under 21 CFR 884.2980. Gst Laboratories of Ca, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1985
Date Received
July 23, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Telethermographic (Adjunctive Use)
Device Class
Class I
Regulation Number
884.2980
Review Panel
RA
Submission Type