FDA 510(k) Application Details - K972176

Device Classification Name Bed, Air Fluidized

  More FDA Info for this Device
510(K) Number K972176
Device Name Bed, Air Fluidized
Applicant KINETIC CONCEPTS, INC.
P.O. BOX 659508
SAN ANTONIO, TX 78265-9508 US
Other 510(k) Applications for this Company
Contact WILLIAM H QUIRK
Other 510(k) Applications for this Contact
Regulation Number 890.5160

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

  More FDA Info for this Product Code
Date Received 06/09/1997
Decision Date 01/16/1998
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