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FDA 510(k)

INSULSCAN INSULATION TESTING SYSTEM

K-Number: K991424 · 1999-07-22

ApplicantMedicor Corp.
Decision Date1999-07-22
Product CodeHFG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INSULSCAN INSULATION TESTING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medicor Corp.. It received FDA 510(k) clearance on 1999-07-22 under 510(k) number K991424. 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 INSULSCAN INSULATION TESTING SYSTEM?

INSULSCAN INSULATION TESTING SYSTEM is a medical device that received FDA 510(k) clearance on 1999-07-22. The listed applicant is Medicor Corp.. The 510(k) number is K991424.

When did INSULSCAN INSULATION TESTING SYSTEM receive FDA 510(k) clearance?

INSULSCAN INSULATION TESTING SYSTEM received FDA 510(k) clearance on 1999-07-22, under 510(k) number K991424.

Who is the listed applicant for INSULSCAN INSULATION TESTING SYSTEM?

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

What is the FDA product code for INSULSCAN INSULATION TESTING SYSTEM?

The FDA product code for INSULSCAN INSULATION TESTING SYSTEM is HFG.

Related Clinical Trials

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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.K101606MICROMED PD-8K INSULATION DEFECT DETECTORMcgan Technology, LLCK961695ENDO-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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