DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100


Device Classification Name

blood pressure cuff

510(k) Number K080854
Device Name DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
Applicant
SUNTECH MEDICAL, INC.
507 airport boulevard
suite 117
morrisville, 
NC 
27560

Applicant Contact david gallik
Correspondent
SUNTECH MEDICAL, INC.
507 airport boulevard
suite 117
morrisville, 
NC 
27560

Correspodent Contact david gallik
Regulation Number 870.1120
Classification Product Code
DXQ  
Date Received 03/27/2008
Decision Date 10/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No