510(k) K792669

COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE by Ge Medical Systems Information Technologies — Product Code HGP

K792669 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on February 11, 1980. The device falls under product code HGP (Electrode, Circular (Spiral), Scalp And Applicator), a Class II device regulated under 21 CFR 884.2675. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1980
Date Received
December 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Circular (Spiral), Scalp And Applicator
Device Class
Class II
Regulation Number
884.2675
Review Panel
OB
Submission Type