CARDIAC TRIGGER MONITOR


Device Classification Name

monitor, cardiac (incl. cardiotachometer & rate alarm)

510(k) Number K110987
Device Name CARDIAC TRIGGER MONITOR
Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 business park dr.
branford, 
CT 
06405

Applicant Contact dick listro
Correspondent
IVY BIOMEDICAL SYSTEMS, INC.
11 business park dr.
branford, 
CT 
06405

Correspodent Contact dick listro
Regulation Number 870.2300
Classification Product Code
DRT  
Date Received 04/08/2011
Decision Date 07/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No