FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Oxygen Concentrator, Model JAY-5AW
K Number: K213210
·
Decision Dec 8, 2022
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
3
Review Days
435
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Basic Information
- Device Name
- Oxygen Concentrator, Model JAY-5AW
- K Number
- K213210
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Longfian Scitech Co., Ltd.
- Date Received
- September 29, 2021
- Decision Date
- December 8, 2022
- Product Code
- CAW
- 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 |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | FDA class 2 | Anesthesiology |
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