FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
K Number: K231414
·
Decision Nov 1, 2023
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
3
Review Days
169
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Basic Information
- Device Name
- CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
- K Number
- K231414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chalice Medical , Ltd.
- Date Received
- May 16, 2023
- Decision Date
- November 1, 2023
- Product Code
- DTZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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