510(k) K033730

PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES by Pmt Corp. — Product Code GZL

K033730 is an FDA 510(k) premarket notification submitted by Pmt Corp. for the device "PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES". The FDA issued a decision of Substantially Equivalent on August 3, 2004. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Pmt Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2004
Date Received
November 28, 2003
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