GUAVA II


Device Classification Name

electrocardiograph

510(k) Number K122632
Device Name GUAVA II
Applicant
CARDIOCOMM SOLUTIONS, INC.
445 apollo beach blvd.
apollo beach, 
FL 
33572

Applicant Contact jonathan ward
Correspondent
CARDIOCOMM SOLUTIONS, INC.
445 apollo beach blvd.
apollo beach, 
FL 
33572

Correspodent Contact jonathan ward
Regulation Number 870.2340
Classification Product Code
DPS  
Subsequent Product Code
DSH  
Date Received 08/29/2012
Decision Date 02/11/2014
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No