HYPER AiR
K-Number: K210001 · 2021-04-30
Device Summary
Frequently Asked Questions
What is the HYPER AiR?
HYPER AiR is a medical device that received FDA 510(k) clearance on 2021-04-30. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K210001.
When did HYPER AiR receive FDA 510(k) clearance?
HYPER AiR received FDA 510(k) clearance on 2021-04-30, under 510(k) number K210001.
Who is the listed applicant for HYPER AiR?
The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HYPER AiR?
The FDA product code for HYPER AiR is KPS.
Other records listing Shanghai United Imaging Healthcare 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: KPS)
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.