FDA 510(k) K042145 READY-HEAT BLANKET

Device Classification Name: Bedding, Disposable, Medical
510(k) Number: K042145
Device Name: READY-HEAT BLANKET
Applicant: TECHTRADE LLC
Regulation Number: 880.6060
Classification Product Code: KME  
Subsequent Product Code: IMD  
Date Received: 08/09/2004
Decision Date: 09/17/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Type: Traditional

Total Pages: 412
Fully Redacted Pages: 260
Content Pages: 152