WALDO PATIENT MONITOR


Device Classification Name

transmitters and receivers, physiological signal, radiofrequency

510(k) Number K110334
Device Name WALDO PATIENT MONITOR
Applicant
WALDO HEALTH
4505 spicewood springs road,
suite 333
austin, 
TX 
78759

Applicant Contact alan r weiss
Correspondent
WALDO HEALTH
4505 spicewood springs road,
suite 333
austin, 
TX 
78759

Correspodent Contact alan r weiss
Regulation Number 870.2910
Classification Product Code
DRG  
Date Received 02/04/2011
Decision Date 04/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No