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FDA 510(k) Applications Submitted by Opsens Inc.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K191907
07/16/2019
OptoWire III
Opsens Inc.
K202943
09/30/2020
OptoMonitor 3
Opsens Inc.
K213854
12/10/2021
SavvyWire
Opsens Inc.
K193620
12/26/2019
OptoMonitor 3
Opsens Inc.
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