Device Classification Name |
ventilator, non-continuous (respirator)
|
510(k) Number |
K121642 |
Device Name |
WIZARD 230 NASAL PILOW MASK |
Applicant |
APEX MEDICAL CORP. |
NO. 9, MINSHENG STREET |
TUCHENG CITY, TAIPEI COUNTY,
TW
236
|
|
Applicant Contact |
FRANK LIN |
Correspondent |
APEX MEDICAL CORP. |
NO. 9, MINSHENG STREET |
TUCHENG CITY, TAIPEI COUNTY,
TW
236
|
|
Correspondent Contact |
FRANK LIN |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 06/04/2012 |
Decision Date | 06/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|