Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K092918 |
Device Name |
PARI VIOS |
Applicant |
PARI RESPIRATORY EQUIPMENT, INC. |
2943 OAK LAKE BLVD. |
MIDLOTHIAN,
VA
23112
|
|
Applicant Contact |
MICHAEL JUDGE |
Correspondent |
PARI RESPIRATORY EQUIPMENT, INC. |
2943 OAK LAKE BLVD. |
MIDLOTHIAN,
VA
23112
|
|
Correspondent Contact |
MICHAEL JUDGE |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/22/2009 |
Decision Date | 02/04/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|