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FDA 510(k)

SOLAR SPO2 MODULE WITH MASIMO SET

K-Number: K002957 · 2000-10-18

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date2000-10-18
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SOLAR SPO2 MODULE WITH MASIMO SET is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 2000-10-18 under 510(k) number K002957. 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 SOLAR SPO2 MODULE WITH MASIMO SET?

SOLAR SPO2 MODULE WITH MASIMO SET is a medical device that received FDA 510(k) clearance on 2000-10-18. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K002957.

When did SOLAR SPO2 MODULE WITH MASIMO SET receive FDA 510(k) clearance?

SOLAR SPO2 MODULE WITH MASIMO SET received FDA 510(k) clearance on 2000-10-18, under 510(k) number K002957.

Who is the listed applicant for SOLAR SPO2 MODULE WITH MASIMO SET?

The FDA 510(k) record lists General Electric Medical Systems Information Techn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLAR SPO2 MODULE WITH MASIMO SET?

The FDA product code for SOLAR SPO2 MODULE WITH MASIMO SET is DQA.

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Other records listing General Electric Medical Systems Information Techn as applicant

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Related Devices (Code: DQA)

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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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