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FDA 510(k)

DA VINCHI EEG AND EMG/EP SYSTEMS

K-Number: K000963 · 2000-10-20

ApplicantAirsep Corp.
Decision Date2000-10-20
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DA VINCHI EEG AND EMG/EP SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 2000-10-20 under 510(k) number K000963. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DA VINCHI EEG AND EMG/EP SYSTEMS?

DA VINCHI EEG AND EMG/EP SYSTEMS is a medical device that received FDA 510(k) clearance on 2000-10-20. The listed applicant is Airsep Corp.. The 510(k) number is K000963.

When did DA VINCHI EEG AND EMG/EP SYSTEMS receive FDA 510(k) clearance?

DA VINCHI EEG AND EMG/EP SYSTEMS received FDA 510(k) clearance on 2000-10-20, under 510(k) number K000963.

Who is the listed applicant for DA VINCHI EEG AND EMG/EP SYSTEMS?

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 EEG AND EMG/EP SYSTEMS?

The FDA product code for DA VINCHI EEG AND EMG/EP SYSTEMS is GWF.

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Other records listing Airsep Corp. as applicant

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.

K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LK080348OXISCAN II DATA MANAGEMENT SYSTEMK020324LIFESTYLE OXYGEN CONCENTRATORK012037HEALTHLIFE OXYGEN CONCENTRATOR MODEL AS009K001579IMPULSE SELECTK001467DA VINCHI EMG/EP ISA1004EP

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Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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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