SENSA-CUFF, MODELS INFANT, CHILD, ADULT


Device Classification Name

blood pressure cuff

510(k) Number K022482
Device Name SENSA-CUFF, MODELS INFANT, CHILD, ADULT
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 woodland corporate blvd.
tampa, 
FL 
33614

Original Contact melissa robinson
Regulation Number 870.1120
Classification Product Code
DXQ  
Date Received 07/29/2002
Decision Date 08/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No