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FDA 510(k), K203155, BreatheSuite MDI V1
FDA 510(k), K203155, BreatheSuite MDI V1
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510(K) Number: K203155
Device Name: BreatheSuite MDI V1
Manufacturer: Brett Vokey
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 10/22/2020
Decision Date: 09/17/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: BreatheSuite MDI V1
Manufacturer: Brett Vokey
Device Classification Name: Nebulizer (Direct Patient Interface)
Regulation Number: CAF
Classification Product Code: KXA
Date Received: 10/22/2020
Decision Date: 09/17/2021
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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