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FDA 510(k)

INSULATION TESTER

K-Number: K120416 · 2012-03-27

ApplicantSpectrum Surgical Supply Corp.
Decision Date2012-03-27
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSULATION TESTER is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Surgical Supply Corp.. It received FDA 510(k) clearance on 2012-03-27 under 510(k) number K120416. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INSULATION TESTER?

INSULATION TESTER is a medical device that received FDA 510(k) clearance on 2012-03-27. The listed applicant is Spectrum Surgical Supply Corp.. The 510(k) number is K120416.

When did INSULATION TESTER receive FDA 510(k) clearance?

INSULATION TESTER received FDA 510(k) clearance on 2012-03-27, under 510(k) number K120416.

Who is the listed applicant for INSULATION TESTER?

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

What is the FDA product code for INSULATION TESTER?

The FDA product code for INSULATION TESTER is GEI.

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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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