FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
Fluido Compact Blood and Fluid Warming System
K Number: K211618
·
Decision Jun 5, 2023
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
74
Applicant Total
3
Review Days
740
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Basic Information
- Device Name
- Fluido Compact Blood and Fluid Warming System
- K Number
- K211618
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Surgical Company International B.V.
- Date Received
- May 26, 2021
- Decision Date
- June 5, 2023
- Product Code
- LGZ
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | FDA class 2 | General Hospital |
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