Device Classification Name |
nebulizer (direct patient interface) |
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---|---|---|---|---|
510(k) Number | K991725 | |||
Device Name | SIDESTREAM NEBULIZER | |||
Applicant |
|
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Applicant Contact | paul e dryden | |||
Correspondent |
|
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Correspodent Contact | paul e dryden | |||
Regulation Number | 868.5630 | |||
Classification Product Code |
|
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Date Received | 05/20/1999 | |||
Decision Date | 07/30/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
|||
510k Review Panel |
Anesthesiology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |