FDA 510(k) Application Details - K032793

Device Classification Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat

  More FDA Info for this Device
510(K) Number K032793
Device Name Diathermy, Ultrasonic, For Use In Applying Therapeutic Deep Heat
Applicant ITO CO., LTD.
2305 GOLD MINE RD.
BROOKEVILLE, MD 20833 US
Other 510(k) Applications for this Company
Contact T. WHIT ATHEY
Other 510(k) Applications for this Contact
Regulation Number 890.5300

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

  More FDA Info for this Product Code
Date Received 09/09/2003
Decision Date 10/09/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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