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FDA 510(k)

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

N.º K: K260931 · 2026-04-14

SolicitanteUnimed Medical Supplies, Inc.
Fecha de decisión2026-04-14
Código de productoDQA
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) is the device name listed in this FDA 510(k) record. The listed applicant is Unimed Medical Supplies, Inc.. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K260931. 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 Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)?

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Unimed Medical Supplies, Inc.. The 510(k) number is K260931.

When did Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) receive FDA 510(k) clearance?

Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) received FDA 510(k) clearance on 2026-04-14, under 510(k) number K260931.

Who is the listed applicant for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)?

The FDA 510(k) record lists Unimed Medical Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)?

The FDA product code for Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) is DQA.

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Otros registros que enlistan a Unimed Medical Supplies, Inc. como solicitante

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K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110-75); Unimed Reusable SpO2 Sensors (-75 Series) (U410S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U110S-75); Unimed Reusable SpO2 Sensors (-75 Series) (U210S-75)

Ver todos los 13 dispositivos →

Dispositivos relacionados (Código: DQA)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 SystemeK252448Pulsoxímetro AViTA (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)Shenzhen Best Electronics Co., Ltd.

Fuente oficial

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