510(k) K830597

BABY CAP, ELECTRODE SET & BOARD ADAPTOR by Precision Cap Systems — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
February 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type