510(k) K960873

MODEL 1210, MEDIUM E-NET by Physiometrix, Inc. — Product Code GXY

K960873 is an FDA 510(k) premarket notification submitted by Physiometrix, Inc. for the device "MODEL 1210, MEDIUM E-NET". The FDA issued a decision of Substantially Equivalent on April 26, 1996. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Physiometrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1996
Date Received
March 4, 1996
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