Device Classification Name |
meter, peak flow, spirometry
|
510(k) Number |
K092335 |
Device Name |
PEAK EXPIRATORY FLOW METER, KN-9710 |
Applicant |
K-JUMP HEALTH CO., LTD. |
NO. 56, WU KUNG 5TH RD., |
WU KU INDUSTRIAL PARK |
TAIPEI HSIEN,
TW
248
|
|
Applicant Contact |
JASON CHENG |
Correspondent |
K-JUMP HEALTH CO., LTD. |
NO. 56, WU KUNG 5TH RD., |
WU KU INDUSTRIAL PARK |
TAIPEI HSIEN,
TW
248
|
|
Correspondent Contact |
JASON CHENG |
Regulation Number | 868.1860
|
Classification Product Code |
|
Date Received | 08/04/2009 |
Decision Date | 04/09/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|