Cleared Traditional

AViTA Pulse Oximeter (SP62B)

K242455 · Avita Corporation · Anesthesiology
Feb 2025
Decision
184d
Days
Class 2
Risk

About This 510(k) Submission

K242455 is an FDA 510(k) clearance for the AViTA Pulse Oximeter (SP62B), a Oximeter (Class II — Special Controls, product code DQA), submitted by Avita Corporation (New Taipei City, TW). The FDA issued a Cleared decision on February 19, 2025, 184 days after receiving the submission on August 19, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K242455 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2024
Decision Date February 19, 2025
Days to Decision 184 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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