510(k) K872044

CARBON ELECTRODE by Futuremed Div. of Future Impex Corp. — Product Code GXY

K872044 is an FDA 510(k) premarket notification submitted by Futuremed Div. of Future Impex Corp. for the device "CARBON ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Futuremed Div. of Future Impex Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 1987
Date Received
May 27, 1987
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