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510(k) K230386

SpassageQ by Spass, Inc. — Product Code PLB

K230386 is an FDA 510(k) premarket notification submitted by Spass, Inc. for the device "SpassageQ". The FDA issued a decision of Substantially Equivalent on June 15, 2023. The device falls under product code PLB (Multivariate Vital Signs Index), a Class II device regulated under 21 CFR 870.2300.

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.

Other clearances for product code PLB

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  • K240558 — NAVOYCDS (July 22, 2024)
  • K213423 — T3 Platform software (January 6, 2023)
  • K183282 — Biovitals Analytics Engine (August 15, 2019)
  • K152258 — T3 Software (March 31, 2016)
  • K142512 — Personalized Physiology Analytics Engine software (June 11, 2015)
  • K843905 — TRAUMA CARE EVALUATION (September 26, 1985)

FDA data resources