ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM


Device Classification Name

electrocardiograph

510(k) Number K050858
Device Name ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM
Applicant
HEARTLAB, INC.
1 crosswind rd.
westerly, 
RI 
02891

Applicant Contact richard petrocelli
Correspondent
HEARTLAB, INC.
1 crosswind rd.
westerly, 
RI 
02891

Correspodent Contact richard petrocelli
Regulation Number 870.2340
Classification Product Code
DPS  
Date Received 04/05/2005
Decision Date 06/29/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls