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FDA 510(k) Application Details - K222569
Device Classification Name
Unit, X-Ray, Extraoral With Timer
More FDA Info for this Device
510(K) Number
K222569
Device Name
Unit, X-Ray, Extraoral With Timer
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park, Guilin National High-Tech Zone
Guilin City 541004 CN
Other 510(k) Applications for this Company
Contact
Xunxian Wu
Other 510(k) Applications for this Contact
Regulation Number
872.1800
More FDA Info for this Regulation Number
Classification Product Code
EHD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/24/2022
Decision Date
11/23/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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