CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES


Device Classification Name

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

510(k) Number K112687
Device Name CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
Applicant
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls, 
NY 
13153 -0220

Applicant Contact kevin crossen
Correspondent
WELCH ALLYN, INC.
4341 state st. rd.
p.o. box 220
skaneateles falls, 
NY 
13153 -0220

Correspodent Contact kevin crossen
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 09/15/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No