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FDA 510(k) Application Details - K201077
Device Classification Name
Recorder, Magnetic Tape, Medical
More FDA Info for this Device
510(K) Number
K201077
Device Name
Recorder, Magnetic Tape, Medical
Applicant
Strados Labs
1315 Walnut Street, Suite 1101
Philadelphia, PA 19107 US
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Contact
Nicholas Delmonico
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
04/22/2020
Decision Date
12/20/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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