SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100


Device Classification Name

system, thermal regulating

510(k) Number K073712
Device Name SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
Applicant
ADROIT MEDICAL SYSTEMS, INC.
1146 carding machine rd.
loudon, 
TN 
37774

Applicant Contact jon r hermanson
Correspondent
ADROIT MEDICAL SYSTEMS, INC.
1146 carding machine rd.
loudon, 
TN 
37774

Correspodent Contact jon r hermanson
Regulation Number 870.5900
Classification Product Code
DWJ  
Date Received 12/31/2007
Decision Date 06/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No