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FDA 510(k)

AViTA Pulse Oximeter (SP61)

K-Number: K252448 · 2026-02-27

ApplicantAvita Corporation
Decision Date2026-02-27
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AViTA Pulse Oximeter (SP61) is a medical device manufactured by Avita Corporation. It received FDA 510(k) clearance on 2026-02-27 under approval number K252448. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AViTA Pulse Oximeter (SP61)?

AViTA Pulse Oximeter (SP61) is a medical device that received FDA 510(k) clearance on 2026-02-27. It is manufactured by Avita Corporation. The 510(k) number is K252448.

When was AViTA Pulse Oximeter (SP61) approved by the FDA?

AViTA Pulse Oximeter (SP61) received FDA 510(k) clearance on 2026-02-27, under approval number K252448.

What company makes AViTA Pulse Oximeter (SP61)?

AViTA Pulse Oximeter (SP61) is manufactured by Avita Corporation.

What is the FDA product code for AViTA Pulse Oximeter (SP61)?

The FDA product code for AViTA Pulse Oximeter (SP61) is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED NCT07527000 SpO2 Validation Study - All.Health Algo Oximeter Software COMPLETED NCT07510451 The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery RECRUITING

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Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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