FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K Number: K211286
·
Decision Nov 16, 2021
Classifications
1
FEI Numbers
141
Registration Numbers
141
Same Product Code
201
Applicant Total
1
Review Days
203
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Basic Information
- Device Name
- Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
- K Number
- K211286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5260
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pall Corporation
- Date Received
- April 27, 2021
- Decision Date
- November 16, 2021
- Product Code
- CAH
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CAH | Filter, Bacterial, Breathing-Circuit | FDA class 2 | Anesthesiology |
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