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FDA 510(k)

PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES

K-Number: K042364 · 2004-09-30

ApplicantLamont Medical, Inc.
Decision Date2004-09-30
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES is the device name listed in this FDA 510(k) record. The listed applicant is Lamont Medical, Inc.. It received FDA 510(k) clearance on 2004-09-30 under 510(k) number K042364. 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 PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES?

PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES is a medical device that received FDA 510(k) clearance on 2004-09-30. The listed applicant is Lamont Medical, Inc.. The 510(k) number is K042364.

When did PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES receive FDA 510(k) clearance?

PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES received FDA 510(k) clearance on 2004-09-30, under 510(k) number K042364.

Who is the listed applicant for PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES?

The FDA 510(k) record lists Lamont Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES?

The FDA product code for PANBUS DIGITAL EEG & SLEEP ACQUISITION DEVICES is OLV.

Related Clinical Trials

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Other records listing Lamont Medical, Inc. 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.

K990522WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS

Related Devices (Code: OLV)

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.

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

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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