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FDA 510(k)

Masimo Rad-97 and Accessories

K-Number: K170168 · 2017-09-14

ApplicantMasimo Corporation
Decision Date2017-09-14
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Rad-97 and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2017-09-14 under 510(k) number K170168. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo Rad-97 and Accessories?

Masimo Rad-97 and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-14. The listed applicant is Masimo Corporation. The 510(k) number is K170168.

When did Masimo Rad-97 and Accessories receive FDA 510(k) clearance?

Masimo Rad-97 and Accessories received FDA 510(k) clearance on 2017-09-14, under 510(k) number K170168.

Who is the listed applicant for Masimo Rad-97 and Accessories?

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-97 and Accessories?

The FDA product code for Masimo Rad-97 and Accessories is MWI.

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.

NCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATEDNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT06922461Clinical Performance of Masimo INVSENSOR00048 (DALI0001)TERMINATEDNCT07223164Validation 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: MWI)

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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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