Device Classification Name |
nebulizer (direct patient interface)
|
510(k) Number |
K100380 |
Device Name |
ALTERA NEBULIZER SYSTEM, MODEL 678G1002 |
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 | 02/16/2010 |
Decision Date | 02/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|