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FDA 510(k)

SNAP II EEG MONITOR

K-Number: K060997 · 2006-06-15

ApplicantEverest Biomedical Instruments Co.
Decision Date2006-06-15
Product CodeOLW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SNAP II EEG MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Everest Biomedical Instruments Co.. It received FDA 510(k) clearance on 2006-06-15 under 510(k) number K060997. 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 SNAP II EEG MONITOR?

SNAP II EEG MONITOR is a medical device that received FDA 510(k) clearance on 2006-06-15. The listed applicant is Everest Biomedical Instruments Co.. The 510(k) number is K060997.

When did SNAP II EEG MONITOR receive FDA 510(k) clearance?

SNAP II EEG MONITOR received FDA 510(k) clearance on 2006-06-15, under 510(k) number K060997.

Who is the listed applicant for SNAP II EEG MONITOR?

The FDA 510(k) record lists Everest Biomedical Instruments Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SNAP II EEG MONITOR?

The FDA product code for SNAP II EEG MONITOR 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 Everest Biomedical Instruments Co. 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.

K024205AUDIOSCREENER OAE+ABR

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

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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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