Device Classification Name |
generator, oxygen, portable |
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---|---|---|---|---|---|
510(k) Number | K121167 | ||||
Device Name | CAIRE COMPANION 5 OXYGEN CONCENTRATOR | ||||
Applicant |
|
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Applicant Contact | ben kadrlik | ||||
Regulation Number | 868.5440 | ||||
Classification Product Code |
|
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Date Received | 04/17/2012 | ||||
Decision Date | 05/02/2012 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
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510k Review Panel |
Anesthesiology |
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statement |
statement |
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Type | Traditional | ||||
Reviewed by Third Party | Yes | ||||
Combination Product |
No |