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 the device name listed in this FDA 510(k) record. The listed applicant is Temed. It received FDA 510(k) clearance on 2018-02-14 under 510(k) 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. The listed applicant is Temed. The 510(k) number is K173545.

When did TEMED Gas Diffuser receive FDA 510(k) clearance?

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

Who is the listed applicant for TEMED Gas Diffuser?

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

What is the FDA product code for TEMED Gas Diffuser?

The FDA product code for TEMED Gas Diffuser is HIF.

Related Devices (Code: HIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KG K242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems Corporation K242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

Official Source

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