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FDA 510(k)

CEREBRAL STATE MONITOR - CSM

K-Number: K042315 · 2005-01-21

ApplicantDanmeter A/S
Decision Date2005-01-21
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CEREBRAL STATE MONITOR - CSM is the device name listed in this FDA 510(k) record. The listed applicant is Danmeter A/S. It received FDA 510(k) clearance on 2005-01-21 under 510(k) number K042315. The device is classified under product code OLW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEREBRAL STATE MONITOR - CSM?

CEREBRAL STATE MONITOR - CSM is a medical device that received FDA 510(k) clearance on 2005-01-21. The listed applicant is Danmeter A/S. The 510(k) number is K042315.

When did CEREBRAL STATE MONITOR - CSM receive FDA 510(k) clearance?

CEREBRAL STATE MONITOR - CSM received FDA 510(k) clearance on 2005-01-21, under 510(k) number K042315.

Who is the listed applicant for CEREBRAL STATE MONITOR - CSM?

The FDA 510(k) record lists Danmeter A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEREBRAL STATE MONITOR - CSM?

The FDA product code for CEREBRAL STATE MONITOR - CSM is OLW.

Related Clinical Trials

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.

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Other records listing Danmeter A/S 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.

K032954ELPHA, MODELS II 500, II 1000, II 2000, II 3000 AND E80K032955AUTOMOVE, MODEL AM800K032988ELPHA 4 CONTI

Related Devices (Code: OLW)

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.

K260907BIS™ Advance pEEG ModuleCovidien LPK260880SedLine Sedation MonitorMasimo CorporationK230693BIS™ Advance Monitoring SystemCovidien, LLCK213273Brain Anesthesia Response Monitor (Bar Monitor)Cortical Dynamics , Ltd.K203113Masimo SedLine Sedation Monitor and AccessoriesMasimo CorporationK202621NeuroSENSE Monitoring System, Model NS-901Neurowave Systems, Inc.

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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