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FDA 510(k), K221614, TytoCare Lung Sounds Analyzer
FDA 510(k), K221614, TytoCare Lung Sounds Analyzer
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510(K) Number: K221614
Device Name: TytoCare Lung Sounds Analyzer
Manufacturer: Stella Raizelman Perry
Device Classification Name: Abnormal Breath Sound Device
Regulation Number: PHZ
Classification Product Code: 06/03/2022
Date Received: 02/24/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: TytoCare Lung Sounds Analyzer
Manufacturer: Stella Raizelman Perry
Device Classification Name: Abnormal Breath Sound Device
Regulation Number: PHZ
Classification Product Code: 06/03/2022
Date Received: 02/24/2023
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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