Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K191270 |
Device Name |
Proneb Max |
Applicant |
PARI Respiratory Equipment, Inc. |
2412 PARI Way |
Midlothian,
VA
23112
|
|
Applicant Contact |
Michael Judge |
Correspondent |
PARI Respiratory Equipment, Inc. |
2412 PARI Way |
Midlothian,
VA
23112
|
|
Correspondent Contact |
Michael Judge |
Regulation Number | 868.5630
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/13/2019 |
Decision Date | 01/23/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|