FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Portable Oxygen Concentrator, model: P2-E6
K Number: K210371
·
Decision Jun 3, 2022
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
286
Applicant Total
5
Review Days
480
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Basic Information
- Device Name
- Portable Oxygen Concentrator, model: P2-E6
- K Number
- K210371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5440
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd.
- Date Received
- February 8, 2021
- Decision Date
- June 3, 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 |
Similar 510(k) Clearances
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Oxygen Concentrator-P2-O5E
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Other Clearances by Qingdao Kingon Medical Science and Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K251764 | Oxygen Concentrator-P2-O5E | Dec 22, 2025 | Substantially Equivalent |
| K242718 | Portable Oxygen Concentrator (P2-TOC) | Feb 28, 2025 | Substantially Equivalent |
| K230702 | Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) | Oct 18, 2023 | Substantially Equivalent |
| K223379 | Portable Oxygen Concentrator (Model: P2-E7, P2-E) | Jun 22, 2023 | Substantially Equivalent |