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FDA 510(k), K220703, F&P 950 Respiratory Humidifier
FDA 510(k), K220703, F&P 950 Respiratory Humidifier
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$49.00 USD
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510(K) Number: K220703
Device Name: F&P 950 Respiratory Humidifier
Manufacturer: Reena Daken
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: KXA
Date Received: 03/10/2022
Decision Date: 06/16/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: F&P 950 Respiratory Humidifier
Manufacturer: Reena Daken
Device Classification Name: Humidifier, Respiratory Gas, (Direct Patient Interface)
Regulation Number: BTT
Classification Product Code: KXA
Date Received: 03/10/2022
Decision Date: 06/16/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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