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FDA 510(k) Application Details - K221530
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K221530
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
Sibel Inc.
6650 W. Touhy Ave.
Niles, IL 60714 US
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Contact
Sarah Coughlin
Other 510(k) Applications for this Contact
Regulation Number
870.2910
More FDA Info for this Regulation Number
Classification Product Code
DRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/26/2022
Decision Date
11/22/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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