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FDA 510(k)

MICROMED PD-8K INSULATION DEFECT DETECTOR

K-Number: K101606 · 2010-10-01

ApplicantMcgan Technology, LLC
Decision Date2010-10-01
Product CodeHFG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

MICROMED PD-8K INSULATION DEFECT DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Mcgan Technology, LLC. It received FDA 510(k) clearance on 2010-10-01 under 510(k) number K101606. The device is classified under product code HFG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROMED PD-8K INSULATION DEFECT DETECTOR?

MICROMED PD-8K INSULATION DEFECT DETECTOR is a medical device that received FDA 510(k) clearance on 2010-10-01. The listed applicant is Mcgan Technology, LLC. The 510(k) number is K101606.

When did MICROMED PD-8K INSULATION DEFECT DETECTOR receive FDA 510(k) clearance?

MICROMED PD-8K INSULATION DEFECT DETECTOR received FDA 510(k) clearance on 2010-10-01, under 510(k) number K101606.

Who is the listed applicant for MICROMED PD-8K INSULATION DEFECT DETECTOR?

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

What is the FDA product code for MICROMED PD-8K INSULATION DEFECT DETECTOR?

The FDA product code for MICROMED PD-8K INSULATION DEFECT DETECTOR is HFG.

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Related Devices (Code: HFG)

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.

K181124Acessa ProVu SystemAcessa Health, Inc.K121858THE ABLATION SYSTEMHalt Medical, Inc.K991424INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.K961695ENDO-TECH LTD., TIPSRatio Design LabK921405DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIPDavol, Inc.K915406DAVOL ELECTROSUGICAL PROBESDavol, Inc.

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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