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FDA 510(k)

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)

K-Number: K233963 · 2025-02-25

ApplicantTaiwan Aulisa Medical Devices Technologies, Inc.
Decision Date2025-02-25
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is a medical device manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2025-02-25 under approval number K233963. 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 Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is a medical device that received FDA 510(k) clearance on 2025-02-25. It is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K233963.

When was Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) approved by the FDA?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) received FDA 510(k) clearance on 2025-02-25, under approval number K233963.

What company makes Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc..

What is the FDA product code for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)?

The FDA product code for Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) is DQA.

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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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