Cleared Traditional

NAVOYCDS

K240558 · Algodx AB · Cardiovascular
Jul 2024
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K240558 is an FDA 510(k) clearance for the NAVOYCDS, a Multivariate Vital Signs Index (Class II — Special Controls, product code PLB), submitted by Algodx AB (Stockholm, SE). The FDA issued a Cleared decision on July 22, 2024, 145 days after receiving the submission on February 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K240558 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2024
Decision Date July 22, 2024
Days to Decision 145 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.