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FDA 510(k)

EQUINOX RELIEVE

K-Number: K113687 · 2012-04-30

ApplicantO-Two Medical Technologies, Inc.
Decision Date2012-04-30
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EQUINOX RELIEVE is the device name listed in this FDA 510(k) record. The listed applicant is O-Two Medical Technologies, Inc.. It received FDA 510(k) clearance on 2012-04-30 under 510(k) number K113687. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EQUINOX RELIEVE?

EQUINOX RELIEVE is a medical device that received FDA 510(k) clearance on 2012-04-30. The listed applicant is O-Two Medical Technologies, Inc.. The 510(k) number is K113687.

When did EQUINOX RELIEVE receive FDA 510(k) clearance?

EQUINOX RELIEVE received FDA 510(k) clearance on 2012-04-30, under 510(k) number K113687.

Who is the listed applicant for EQUINOX RELIEVE?

The FDA 510(k) record lists O-Two Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EQUINOX RELIEVE?

The FDA product code for EQUINOX RELIEVE is BZR.

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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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