Puritan Bennett Cuff Pressure Manager
FDA 510(k) K202874 · Covidien, LLC
510(k) numberK202874
Submission
- Device name
- Puritan Bennett Cuff Pressure Manager
- Applicant
- Covidien, LLC
Shanghai, CN - Received
- September 28, 2020
- Decision date
- January 9, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSK – Cuff, Tracheal Tube, Inflatable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5750
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Puritan Bennett Cuff Pressure Manager cleared by the FDA?
Puritan Bennett Cuff Pressure Manager (K202874) received a 510(k) decision of Substantially Equivalent on January 9, 2021, 103 days after the submission was received.
What is the product code of K202874?
The FDA product code is BSK – Cuff, Tracheal Tube, Inflatable, a Class II (moderate risk) device regulated under 21 CFR 868.5750.