8100 VITAL SIGNS MONITOR


codes

Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K001020
Device Name 8100 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
MWI  
Date Received 03/30/2000
Decision Date 04/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No