Device Classification Name |
attachment, breathing, positive end expiratory pressure |
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---|---|---|---|---|---|
510(k) Number | K122610 | ||||
Device Name | PLAXTRON CPAP SYSTEM, MODEL CH-FFM-87XX/CH-FFM-88XX SERIES | ||||
Applicant |
|
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Applicant Contact | ming-yie jn, ph.d. | ||||
Correspondent |
|
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Correspodent Contact | ming-yie jn, ph.d. | ||||
Regulation Number | 868.5965 | ||||
Classification Product Code |
|
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Date Received | 08/27/2012 | ||||
Decision Date | 08/05/2013 | ||||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Anesthesiology |
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510k Review Panel |
Anesthesiology |
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summary |
summary |
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Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |