510(k) K760503

STIMULATOR, ELECTRICAL MUSCLE (#MD-8) by R. A. Fischer Co. Corp. — Product Code IPF

K760503 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "STIMULATOR, ELECTRICAL MUSCLE (#MD-8)". The FDA issued a decision of Substantially Equivalent on September 27, 1976. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1976
Date Received
August 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type