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FDA 510(k)

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)

K-Number: K233956 · 2025-01-30

ApplicantTaiwan Aulisa Medical Devices Technologies, Inc.
Decision Date2025-01-30
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) is a medical device manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2025-01-30 under approval number K233956. 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 Infant Oximeter Module (2nd Gen.) (GA-OM0018)?

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) is a medical device that received FDA 510(k) clearance on 2025-01-30. It is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K233956.

When was Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) approved by the FDA?

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) received FDA 510(k) clearance on 2025-01-30, under approval number K233956.

What company makes Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)?

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc..

What is the FDA product code for Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)?

The FDA product code for Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) 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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