FDA 510(k) Application Details - K970074

Device Classification Name Warmer, Infant Radiant

  More FDA Info for this Device
510(K) Number K970074
Device Name Warmer, Infant Radiant
Applicant HILL-ROM, INC.
1069 STATE ROUTE 46 EAST
BATESVILLE, IN 47006 US
Other 510(k) Applications for this Company
Contact JAMES G CARPENTER
Other 510(k) Applications for this Contact
Regulation Number 880.5130

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

  More FDA Info for this Product Code
Date Received 01/08/1997
Decision Date 04/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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