510(k) K780698

STIMULATORS, NERVE, ELECTRICAL by Med General — Product Code GZJ

K780698 is an FDA 510(k) premarket notification submitted by Med General for the device "STIMULATORS, NERVE, ELECTRICAL". The FDA issued a decision of Substantially Equivalent on May 12, 1978. The device falls under product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief), a Class II device regulated under 21 CFR 882.5890. Med General has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1978
Date Received
April 26, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type