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510(k) K223818

Model 9160 VitaloQUB by Vitalograph Ireland, Ltd. — Product Code JEH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2023
Date Received
December 21, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Volume
Device Class
Class II
Regulation Number
868.1760
Review Panel
AN
Submission Type

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  • K925040 — TELEPULSE (August 23, 1993)
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