HOTDOG PATIENT WARMING SYSTEM


Device Classification Name

system, thermal regulating

510(k) Number K112488
Device Name HOTDOG PATIENT WARMING SYSTEM
Applicant
AUGUSTINE BIOMEDICAL & DESIGN, LLC
6581 city west parkway
eden prairie, 
MN 
55344

Applicant Contact wendy nelson
Correspondent
AUGUSTINE BIOMEDICAL & DESIGN, LLC
6581 city west parkway
eden prairie, 
MN 
55344

Correspodent Contact wendy nelson
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 08/29/2011
Decision Date 11/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No