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FDA 510(k)

Masimo Rad-G with Temperature

K-Number: K213676 · 2023-04-16

ApplicantMasimo Corporation
Decision Date2023-04-16
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Rad-G with Temperature is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2023-04-16 under 510(k) number K213676. 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 Masimo Rad-G with Temperature?

Masimo Rad-G with Temperature is a medical device that received FDA 510(k) clearance on 2023-04-16. The listed applicant is Masimo Corporation. The 510(k) number is K213676.

When did Masimo Rad-G with Temperature receive FDA 510(k) clearance?

Masimo Rad-G with Temperature received FDA 510(k) clearance on 2023-04-16, under 510(k) number K213676.

Who is the listed applicant for Masimo Rad-G with Temperature?

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

What is the FDA product code for Masimo Rad-G with Temperature?

The FDA product code for Masimo Rad-G with Temperature is DQA.

Related Clinical Trials

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.

NCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATEDNCT06922461Clinical Performance of Masimo INVSENSOR00048 (DALI0001)TERMINATEDNCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT07223164Validation of the Masimo Irregular Heartbeat Detection Algorithm in Participants Without Cardiovascular DiseaseCOMPLETED

Other records listing Masimo 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.

K253417Masimo Root Monitoring SystemK260880SedLine Sedation MonitorK254209Radius VSM and AccessoriesK243324Masimo O3 Regional OximeterK250757Radius VSM and AccessoriesK243305Masimo W1

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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.

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