FDA 510(k)

VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM

K-Number: K002422 · 2000-08-31

Decision Date2000-08-31

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mitek Products. It received FDA 510(k) clearance on 2000-08-31 under 510(k) number K002422. 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 VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM?

VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM is a medical device that received FDA 510(k) clearance on 2000-08-31. The listed applicant is Mitek Products. The 510(k) number is K002422.

When did VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM receive FDA 510(k) clearance?

VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM received FDA 510(k) clearance on 2000-08-31, under 510(k) number K002422.

Who is the listed applicant for VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM?

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

What is the FDA product code for VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM?

The FDA product code for VARPR 3.5MM 90 SUCTION ELECTRODE FOR USE WITH VAPR SYSTEM 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.