GOLDWAY PATIENT MONITOR, MODEL # UT4000F


Device Classification Name

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

510(k) Number K021154
Device Name GOLDWAY PATIENT MONITOR, MODEL # UT4000F
Original Applicant
GOLDWAY US, INC.
12 south first street,
suite 1205
san jose, 
CA 
95113

Original Contact y. justin chen
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 04/10/2002
Decision Date 04/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No