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FDA 510(k)

DA VINCHI EMG/EP ISA1004EP

K-Number: K001467 · 2000-08-01

ApplicantAirsep Corp.
Decision Date2000-08-01
Product CodeGWE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DA VINCHI EMG/EP ISA1004EP is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 2000-08-01 under 510(k) number K001467. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DA VINCHI EMG/EP ISA1004EP?

DA VINCHI EMG/EP ISA1004EP is a medical device that received FDA 510(k) clearance on 2000-08-01. The listed applicant is Airsep Corp.. The 510(k) number is K001467.

When did DA VINCHI EMG/EP ISA1004EP receive FDA 510(k) clearance?

DA VINCHI EMG/EP ISA1004EP received FDA 510(k) clearance on 2000-08-01, under 510(k) number K001467.

Who is the listed applicant for DA VINCHI EMG/EP ISA1004EP?

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

What is the FDA product code for DA VINCHI EMG/EP ISA1004EP?

The FDA product code for DA VINCHI EMG/EP ISA1004EP is GWE.

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Other records listing Airsep Corp. as applicant

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Related Devices (Code: GWE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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