Cleared Traditional

SpassageQ

K230386 · Spass, Inc. · Cardiovascular
Jun 2023
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K230386 is an FDA 510(k) clearance for the SpassageQ, a Multivariate Vital Signs Index (Class II — Special Controls, product code PLB), submitted by Spass, Inc. (Seoul, KR). The FDA issued a Cleared decision on June 15, 2023, 121 days after receiving the submission on February 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K230386 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2023
Decision Date June 15, 2023
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PLB — Multivariate Vital Signs Index
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.