BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM


Device Classification Name

plethysmograph, impedance

510(k) Number K080941
Device Name BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
Applicant
N.I. MEDICAL, LTD.
414 maryjoe way
warrington, 
PA 
18976

Applicant Contact james collie
Correspondent
N.I. MEDICAL, LTD.
414 maryjoe way
warrington, 
PA 
18976

Correspodent Contact james collie
Regulation Number 870.2770
Classification Product Code
DSB  
Date Received 04/03/2008
Decision Date 06/18/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No