HYPER AiR

System, Tomography, Computed, Emission

Shanghai United Imaging Healthcare Co.,Ltd.

The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co.,ltd. with the FDA for Hyper Air.

Pre-market Notification Details

Device IDK210001
510k NumberK210001
Device Name:HYPER AiR
ClassificationSystem, Tomography, Computed, Emission
Applicant Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
ContactXin Gao
CorrespondentXin Gao
Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai,  CN 201807
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-04
Decision Date2021-04-30

Trademark Results [HYPER AiR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYPER AIR
HYPER AIR
78439495 not registered Dead/Abandoned
Alpine Technologies, Inc.
2004-06-22
HYPER AIR
HYPER AIR
74610886 2112623 Dead/Cancelled
BRAVO SPORTS
1994-12-14

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