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FDA 510(k)

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY

K-Number: K001013 · 2000-05-16

ApplicantAirsep Corp.
Decision Date2000-05-16
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Airsep Corp.. It received FDA 510(k) clearance on 2000-05-16 under 510(k) number K001013. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY?

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY is a medical device that received FDA 510(k) clearance on 2000-05-16. The listed applicant is Airsep Corp.. The 510(k) number is K001013.

When did MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY receive FDA 510(k) clearance?

MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY received FDA 510(k) clearance on 2000-05-16, under 510(k) number K001013.

Who is the listed applicant for MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY?

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 MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY?

The FDA product code for MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY is OLV.

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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 AS009K000963DA VINCHI EEG AND EMG/EP SYSTEMSK001579IMPULSE SELECT

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Related Devices (Code: OLV)

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K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra Medical , Ltd.

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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