Device Classification Name |
Humidifier, Respiratory Gas, (Direct Patient Interface)
|
510(k) Number |
K193411 |
Device Name |
O2asis Personal Oxygen Humidifier |
Applicant |
Perma Pure LLC |
1001 New Hampshire Ave |
Lakewood,
NJ
08701
|
|
Applicant Contact |
Sidra Hankins |
Correspondent |
Perma Pure LLC c/o ProMedic, LLC |
131 Bay Point Dr. NE |
St. Petersburg,
FL
33704
|
|
Correspondent Contact |
Paul Dryden |
Regulation Number | 868.5450
|
Classification Product Code |
|
Date Received | 12/09/2019 |
Decision Date | 11/12/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|