510(k) K964208

MD-1A GALVANIC UNIT by R. A. Fischer Co. Corp. — Product Code EGJ

K964208 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "MD-1A GALVANIC UNIT". The FDA issued a decision of Substantially Equivalent on April 30, 1997. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 1997
Date Received
October 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type