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FDA 510(k)

HI-OX

K-Number: K020665 · 2002-07-30

ApplicantSensor Medics Corp.
Decision Date2002-07-30
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HI-OX is the device name listed in this FDA 510(k) record. The listed applicant is Sensor Medics Corp.. It received FDA 510(k) clearance on 2002-07-30 under 510(k) number K020665. The device is classified under product code CBP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HI-OX?

HI-OX is a medical device that received FDA 510(k) clearance on 2002-07-30. The listed applicant is Sensor Medics Corp.. The 510(k) number is K020665.

When did HI-OX receive FDA 510(k) clearance?

HI-OX received FDA 510(k) clearance on 2002-07-30, under 510(k) number K020665.

Who is the listed applicant for HI-OX?

The FDA 510(k) record lists Sensor Medics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-OX?

The FDA product code for HI-OX is CBP.

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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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