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510(k) K230386

SpassageQ by Spass, Inc. — Product Code PLB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2023
Date Received
February 14, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multivariate Vital Signs Index
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.

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