PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)


Device Classification Name

monitor, cardiac (incl. cardiotachometer & rate alarm)

510(k) Number K023616
Device Name PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)
Original Applicant
IVY BIOMEDICAL SYSTEMS, INC.
11 business park dr.
branford, 
CT 
06405

Original Contact dick listro
Regulation Number 870.2300
Classification Product Code
DRT  
Date Received 10/29/2002
Decision Date 11/04/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No