FLEXIPORT ECOCUFF


Device Classification Name

blood pressure cuff

510(k) Number K122058
Device Name FLEXIPORT ECOCUFF
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 870.1120
Classification Product Code
DXQ  
Date Received 07/13/2012
Decision Date 11/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No