GALEMED PEAK FLOW METER, MODELS 3751/3752


Device Classification Name

meter, peak flow, spirometry

510(k) Number K022124
Device Name GALEMED PEAK FLOW METER, MODELS 3751/3752
Original Applicant
GALEMED CORP.
87, li-gong 2nd rd.,
wu-jia, i-lan, 

TW

268

Original Contact bruce kuo
Regulation Number 868.1860
Classification Product Code
BZH  
Date Received 07/01/2002
Decision Date 04/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No