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FDA 510(k)

HYPEROX 101

K-Number: K053498 · 2006-03-15

ApplicantWjo, Inc.
Decision Date2006-03-15
Product CodeCBF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPEROX 101 is the device name listed in this FDA 510(k) record. The listed applicant is Wjo, Inc.. It received FDA 510(k) clearance on 2006-03-15 under 510(k) number K053498. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPEROX 101?

HYPEROX 101 is a medical device that received FDA 510(k) clearance on 2006-03-15. The listed applicant is Wjo, Inc.. The 510(k) number is K053498.

When did HYPEROX 101 receive FDA 510(k) clearance?

HYPEROX 101 received FDA 510(k) clearance on 2006-03-15, under 510(k) number K053498.

Who is the listed applicant for HYPEROX 101?

The FDA 510(k) record lists Wjo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPEROX 101?

The FDA product code for HYPEROX 101 is CBF.

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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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