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FDA 510(k)

MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8

K-Number: K092838 · 2009-10-15

ApplicantMasimo Corporation
Decision Date2009-10-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2009-10-15 under 510(k) number K092838. 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 SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8?

MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 is a medical device that received FDA 510(k) clearance on 2009-10-15. The listed applicant is Masimo Corporation. The 510(k) number is K092838.

When did MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 receive FDA 510(k) clearance?

MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 received FDA 510(k) clearance on 2009-10-15, under 510(k) number K092838.

Who is the listed applicant for MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8?

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 SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8?

The FDA product code for MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8 is DQA.

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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.

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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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