Device Classification Name |
Ventilator, Non-Continuous (Respirator)
|
510(k) Number |
K182394 |
Device Name |
WiZARD 310/320 Series CPAP Mask |
Applicant |
Apex Medical Corp. |
No. 9 Min Sheng St. Tu-Cheng |
New Taipei City,
TW
23679
|
|
Applicant Contact |
Frank Lin |
Correspondent |
Apex Medical Corp. |
No. 9 Min Sheng St. Tu-Cheng |
New Taipei City,
TW
23679
|
|
Correspondent Contact |
Frank Lin |
Regulation Number | 868.5905
|
Classification Product Code |
|
Date Received | 09/04/2018 |
Decision Date | 05/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|