510(k) K964644

AD-TECH'S DEPTH ELECTRODE by Ad-Tech Medical Instrument Corp — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1997
Date Received
October 31, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type