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FDA 510(k)

Masimo Rad-67 Pulse CO-Oximeter and Accessories

K-Number: K182887 · 2019-03-22

Decision Date2019-03-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Rad-67 Pulse CO-Oximeter 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 2019-03-22 under 510(k) number K182887. 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-67 Pulse CO-Oximeter and Accessories?

Masimo Rad-67 Pulse CO-Oximeter and Accessories is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Masimo Corporation. The 510(k) number is K182887.

When did Masimo Rad-67 Pulse CO-Oximeter and Accessories receive FDA 510(k) clearance?

Masimo Rad-67 Pulse CO-Oximeter and Accessories received FDA 510(k) clearance on 2019-03-22, under 510(k) number K182887.

Who is the listed applicant for Masimo Rad-67 Pulse CO-Oximeter 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-67 Pulse CO-Oximeter and Accessories?

The FDA product code for Masimo Rad-67 Pulse CO-Oximeter and Accessories 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.

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.

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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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.