FDA 510(k)

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

N.º K: K233956 · 2025-01-30

SolicitanteTaiwan Aulisa Medical Devices Technologies, Inc.

Fecha de decisión2025-01-30

Código de productoDQA

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2025-01-30 under 510(k) number K233956. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

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. The listed applicant is Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K233956.

When did Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) receive FDA 510(k) clearance?

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

Who is the listed applicant for Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)?

The FDA 510(k) record lists Taiwan Aulisa Medical Devices Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Otros registros que enlistan a Taiwan Aulisa Medical Devices Technologies, Inc. como solicitante

K233963Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)K240220Aulisa Temperature Module (TM0002)K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System K191207Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse 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 Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448Pulsoxímetro AViTA (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Fuente oficial

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