507EL VITAL SIGNS MONITOR


Device Classification Name

monitor, cardiac (incl. cardiotachometer & rate alarm)

510(k) Number K022435
Device Name 507EL VITAL SIGNS MONITOR
Original Applicant
CRITICARE SYSTEMS, INC.
20925 crossroads circle
waukesha, 
WI 
53186

Original Contact alex kaplan
Regulation Number 870.2300
Classification Product Code
DRT  
Date Received 07/25/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No