| 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 |
||||
| statement |
statement |
||||
| Type | Traditional | ||||
| Reviewed by Third Party | Yes | ||||
| Combination Product |
No |