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FDA 510(k)

MODIFICATION TO HIOX

K-Number: K030943 · 2003-04-22

ApplicantSensor Medics Corp.
Decision Date2003-04-22
Product CodeCBP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HIOX 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 2003-04-22 under 510(k) number K030943. 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 MODIFICATION TO HIOX?

MODIFICATION TO HIOX is a medical device that received FDA 510(k) clearance on 2003-04-22. The listed applicant is Sensor Medics Corp.. The 510(k) number is K030943.

When did MODIFICATION TO HIOX receive FDA 510(k) clearance?

MODIFICATION TO HIOX received FDA 510(k) clearance on 2003-04-22, under 510(k) number K030943.

Who is the listed applicant for MODIFICATION TO HIOX?

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 MODIFICATION TO HIOX?

The FDA product code for MODIFICATION TO HIOX is CBP.

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Other records listing Sensor Medics Corp. as applicant

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Related Devices (Code: 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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