Device Classification Name |
pump, infusion |
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---|---|---|---|---|
510(k) Number | K002380 | |||
Device Name | INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM | |||
Original Applicant |
|
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Original Contact | vicki l drews | |||
Regulation Number | 880.5725 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
|||
Date Received | 08/04/2000 | |||
Decision Date | 09/05/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
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510k Review Panel |
General Hospital |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |