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FDA 510(k) Application Details - K223073
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K223073
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
Alio, Inc.
10901 W. 120th Ave, Suite 380
Broomfield, CO 80021 US
Other 510(k) Applications for this Company
Contact
Kimberly Snyder
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
09/30/2022
Decision Date
03/17/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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