Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
Summary
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. received 510(k) clearance for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A, a CAW device. Cleared on 2023-04-28.
Details
Source
510(k) Clearance
External ID
K213825
Action Date
2023-04-28
Status
Traditional
Category
device
Product Code
CAW
Product Description
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A. Product code: CAW.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has received 7 total clearances in our database.
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has 7 FDA actions in our database, including 7 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. have FDA actions?
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has 7 FDA actions in our database, including 0 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213825" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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