Device Classification Name |
Meter, Peak Flow, Spirometry
|
510(k) Number |
K022124 |
Device Name |
GALEMED PEAK FLOW METER, MODELS 3751/3752 |
Applicant |
GALEMED CORP. |
87, LI-GONG 2ND RD., |
WU-JIA, I-LAN,
TW
268
|
|
Applicant Contact |
BRUCE KUO |
Correspondent |
GALEMED CORP. |
87, LI-GONG 2ND RD., |
WU-JIA, I-LAN,
TW
268
|
|
Correspondent Contact |
BRUCE KUO |
Regulation Number | 868.1860
|
Classification Product Code |
|
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
|
|
|