510(k) K914621

IONTOPHORESIS DEVICE, MODIFICATION by Iomed, Inc. — Product Code EGJ

K914621 is an FDA 510(k) premarket notification submitted by Iomed, Inc. for the device "IONTOPHORESIS DEVICE, MODIFICATION". The FDA issued a decision of Substantially Equivalent (kit, denovo) on December 20, 1991. The device falls under product code EGJ (Device, Iontophoresis, Other Uses), a Class II device regulated under 21 CFR 890.5525. Iomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
December 20, 1991
Date Received
September 11, 1991
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