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FDA 510(k), K181524, Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
FDA 510(k), K181524, Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
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$149.00 USD
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$149.00 USD
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510(K) Number: K181524
Device Name: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
Manufacturer: Vyaire Medical, Inc.
Device Classification Name: calculator, pulmonary function data
Regulation Number: 868.1880
Classification Product Code: BZC
Date Received: 06/11/2018
Decision Date: 11/30/2018
Regulation Medical Specialty: Anesthesiology
Device Name: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
Manufacturer: Vyaire Medical, Inc.
Device Classification Name: calculator, pulmonary function data
Regulation Number: 868.1880
Classification Product Code: BZC
Date Received: 06/11/2018
Decision Date: 11/30/2018
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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