Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A
K-Number: K213825 · 2023-04-28
Device Summary
Frequently Asked Questions
What is the Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is a medical device that received FDA 510(k) clearance on 2023-04-28. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K213825.
When did Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A receive FDA 510(k) clearance?
Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A received FDA 510(k) clearance on 2023-04-28, under 510(k) number K213825.
Who is the listed applicant for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?
The FDA 510(k) record lists Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A?
The FDA product code for Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A is CAW.
Other records listing Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: CAW)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.