510(k) K041604

MACRO-MICRO DEPTH ELECTRODE by Ad-Tech Medical Instrument Corp — Product Code GZL

K041604 is an FDA 510(k) premarket notification submitted by Ad-Tech Medical Instrument Corp for the device "MACRO-MICRO DEPTH ELECTRODE". The FDA issued a decision of Substantially Equivalent on August 16, 2004. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Ad-Tech Medical Instrument Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2004
Date Received
June 14, 2004
Clearance Type
Abbreviated
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