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FDA 510(k), K771368, PORTABLE INFANT VENTILATOR
FDA 510(k), K771368, PORTABLE INFANT VENTILATOR
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510(K) Number: K771368
Device Name: PORTABLE INFANT VENTILATOR
Manufacturer:
Device Classification Name: Bag, Urine Collection, Newborn
Regulation Number: FOC
Classification Product Code: 07/25/1977
Date Received: 08/04/1977
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PORTABLE INFANT VENTILATOR
Manufacturer:
Device Classification Name: Bag, Urine Collection, Newborn
Regulation Number: FOC
Classification Product Code: 07/25/1977
Date Received: 08/04/1977
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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