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FDA 510(k) Application Details - K210019
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
More FDA Info for this Device
510(K) Number
K210019
Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan
Shenzhen 518108 CN
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Contact
Linbin Ye
Other 510(k) Applications for this Contact
Regulation Number
868.1400
More FDA Info for this Regulation Number
Classification Product Code
CCK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/04/2021
Decision Date
03/04/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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