Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K112859 |
Device Name |
ERAPID NEBULIZER SYSTEM |
Applicant |
PARI RESPIRATORY EQUIPMENT, INC. |
2943 OAKLAKE BLVD. |
MIDLOTHIAN,
VA
23112
|
|
Applicant Contact |
JAMES L MCINTIRE |
Correspondent |
PARI RESPIRATORY EQUIPMENT, INC. |
2943 OAKLAKE BLVD. |
MIDLOTHIAN,
VA
23112
|
|
Correspondent Contact |
JAMES L MCINTIRE |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 05/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|