Cleared Traditional

HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta? Advanced Monitor (Smart Recovery); HemoSphere Alta? Advanced Monitor (Cardiac); HemoSphere Alta? Advanced Monitor (All-on-One)

K232294 · Edwards Lifesciences, LLC · Cardiovascular
Oct 2023
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K232294 is an FDA 510(k) clearance for the HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta? Advanced Monitor (Smart Recovery); HemoSphere Alta? Advanced Monitor (Cardiac); HemoSphere Alta? Advanced Monitor (All-on-One), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on October 31, 2023, 91 days after receiving the submission on August 1, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K232294 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2023
Decision Date October 31, 2023
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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