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FDA 510(k), K202874, Puritan Bennett Cuff Pressure Manager
FDA 510(k), K202874, Puritan Bennett Cuff Pressure Manager
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510(K) Number: K202874
Device Name: Puritan Bennett Cuff Pressure Manager
Manufacturer: Jenny Liu
Device Classification Name: Cuff, Tracheal Tube, Inflatable
Regulation Number: BSK
Classification Product Code: KXA
Date Received: 09/28/2020
Decision Date: 01/09/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: Puritan Bennett Cuff Pressure Manager
Manufacturer: Jenny Liu
Device Classification Name: Cuff, Tracheal Tube, Inflatable
Regulation Number: BSK
Classification Product Code: KXA
Date Received: 09/28/2020
Decision Date: 01/09/2021
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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