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FDA 510(k) Application Details - K214073
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K214073
Device Name
Recorder, Magnetic Tape, Medical
Applicant
WearLinq, Inc.
1819 Polk St #148
San Francisco, CA 94109 US
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Contact
Konrad Morzkowski
Other 510(k) Applications for this Contact
Regulation Number
870.2800
More FDA Info for this Regulation Number
Classification Product Code
DSH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/27/2021
Decision Date
10/20/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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