510(k) K802151

PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC by Progress Mankind Technology — Product Code GZL

K802151 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "PMT DEPTHALON DEPTH CORTICOGRAPHY ELEC". The FDA issued a decision of Substantially Equivalent on November 19, 1980. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Progress Mankind Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1980
Date Received
September 8, 1980
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