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FDA 510(k)

CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR

K-Number: K082853 · 2009-03-23

ApplicantInspired Technologies, Inc.
Decision Date2009-03-23
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR is the device name listed in this FDA 510(k) record. The listed applicant is Inspired Technologies, Inc.. It received FDA 510(k) clearance on 2009-03-23 under 510(k) number K082853. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR?

CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR is a medical device that received FDA 510(k) clearance on 2009-03-23. The listed applicant is Inspired Technologies, Inc.. The 510(k) number is K082853.

When did CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR receive FDA 510(k) clearance?

CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR received FDA 510(k) clearance on 2009-03-23, under 510(k) number K082853.

Who is the listed applicant for CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR?

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

What is the FDA product code for CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR?

The FDA product code for CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR is MNR.

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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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