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FDA 510(k)

OXYFRESH OXYCARE 3000

K-Number: K910832 · 1991-04-17

ApplicantOxyfresh
Decision Date1991-04-17
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OXYFRESH OXYCARE 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Oxyfresh. It received FDA 510(k) clearance on 1991-04-17 under 510(k) number K910832. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYFRESH OXYCARE 3000?

OXYFRESH OXYCARE 3000 is a medical device that received FDA 510(k) clearance on 1991-04-17. The listed applicant is Oxyfresh. The 510(k) number is K910832.

When did OXYFRESH OXYCARE 3000 receive FDA 510(k) clearance?

OXYFRESH OXYCARE 3000 received FDA 510(k) clearance on 1991-04-17, under 510(k) number K910832.

Who is the listed applicant for OXYFRESH OXYCARE 3000?

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

What is the FDA product code for OXYFRESH OXYCARE 3000?

The FDA product code for OXYFRESH OXYCARE 3000 is EFS.

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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.

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