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FDA 510(k)

TEMED Gas Diffuser

K-Number: K173545 · 2018-02-14

ApplicantTemed
Decision Date2018-02-14
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TEMED Gas Diffuser is a medical device manufactured by Temed. It received FDA 510(k) clearance on 2018-02-14 under approval number K173545. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMED Gas Diffuser?

TEMED Gas Diffuser is a medical device that received FDA 510(k) clearance on 2018-02-14. It is manufactured by Temed. The 510(k) number is K173545.

When was TEMED Gas Diffuser approved by the FDA?

TEMED Gas Diffuser received FDA 510(k) clearance on 2018-02-14, under approval number K173545.

What company makes TEMED Gas Diffuser?

TEMED Gas Diffuser is manufactured by Temed.

What is the FDA product code for TEMED Gas Diffuser?

The FDA product code for TEMED Gas Diffuser is HIF.

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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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