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FDA 510(k), K192595, ExSpiron 2Xi
FDA 510(k), K192595, ExSpiron 2Xi
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510(K) Number: K192595
Device Name: ExSpiron 2Xi
Manufacturer: Susan K. Hamann
Device Classification Name: Spirometer, Monitoring (W/Wo Alarm)
Regulation Number: BZK
Classification Product Code: 09/20/2019
Date Received: 12/17/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ExSpiron 2Xi
Manufacturer: Susan K. Hamann
Device Classification Name: Spirometer, Monitoring (W/Wo Alarm)
Regulation Number: BZK
Classification Product Code: 09/20/2019
Date Received: 12/17/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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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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