Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AViTA Pulse Oximeter

K-Number: K223399 · 2024-05-20

ApplicantAvita Corporation
Decision Date2024-05-20
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AViTA Pulse Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2024-05-20 under 510(k) number K223399. 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?

AViTA Pulse Oximeter is a medical device that received FDA 510(k) clearance on 2024-05-20. The listed applicant is Avita Corporation. The 510(k) number is K223399.

When did AViTA Pulse Oximeter receive FDA 510(k) clearance?

AViTA Pulse Oximeter received FDA 510(k) clearance on 2024-05-20, under 510(k) number K223399.

Who is the listed applicant for AViTA Pulse Oximeter?

The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AViTA Pulse Oximeter?

The FDA product code for AViTA Pulse Oximeter is DQA.

Other records listing Avita Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250129AViTA Breast PumpK252448AViTA Pulse Oximeter (SP61)K250765AViTA Arm Type Blood Pressure Monitor CuffK242455AViTA Pulse Oximeter (SP62B)K241852Nasal Aspirator (NS 13)K242193Arm Type Blood Pressure Monitor (BPM82)

View all 10 devices →

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply 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.

↑