FDA 510(k) Application Details - K974855

Device Classification Name Device, Iontophoresis, Specific Uses

  More FDA Info for this Device
510(K) Number K974855
Device Name Device, Iontophoresis, Specific Uses
Applicant IOMED, INC.
3385 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104 US
Other 510(k) Applications for this Company
Contact W. TIM MILLER
Other 510(k) Applications for this Contact
Regulation Number 890.5525

  More FDA Info for this Regulation Number
Classification Product Code KTB
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/29/1997
Decision Date 03/27/1998
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact