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FDA 510(k)

MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS

K-Number: K120657 · 2012-09-19

ApplicantMasimo Corporation
Decision Date2012-09-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K120657. 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 AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS?

MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Masimo Corporation. The 510(k) number is K120657.

When did MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS receive FDA 510(k) clearance?

MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS received FDA 510(k) clearance on 2012-09-19, under 510(k) number K120657.

Who is the listed applicant for MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS?

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 AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS?

The FDA product code for MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS 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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