FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Nihon Kohden NKV-330 Ventilator System
K Number: K213521
·
Decision Jul 1, 2022
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
24
Applicant Total
4
Review Days
240
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Basic Information
- Device Name
- Nihon Kohden NKV-330 Ventilator System
- K Number
- K213521
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nihon Kohden Orangemed, Inc.
- Date Received
- November 3, 2021
- Decision Date
- July 1, 2022
- Product Code
- MNT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| MNT | Sv70 Ventilator | FDA class 2 | Anesthesiology |
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