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FDA 510(k)

OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330

K-Number: K020335 · 2002-06-18

ApplicantOlympic Medical Corp.
Decision Date2002-06-18
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 is the device name listed in this FDA 510(k) record. The listed applicant is Olympic Medical Corp.. It received FDA 510(k) clearance on 2002-06-18 under 510(k) number K020335. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330?

OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 is a medical device that received FDA 510(k) clearance on 2002-06-18. The listed applicant is Olympic Medical Corp.. The 510(k) number is K020335.

When did OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 receive FDA 510(k) clearance?

OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 received FDA 510(k) clearance on 2002-06-18, under 510(k) number K020335.

Who is the listed applicant for OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330?

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

What is the FDA product code for OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330?

The FDA product code for OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 is OMC.

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Other records listing Olympic Medical 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.

K081094OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500K031149OLYMPIC CFM 6000K001056OLYMPIC WARM-UPK983229OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEMK971601OLYMPIC BILI-BASSINETK972193OLYMPIX MINI-PASTEURMATIC (58210)

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Related Devices (Code: OMC)

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.

K261101Ceribell MonitorCeribell, Inc.K251550NX01 (NX01)Naox Technologies SasK251726SignalNED System (Model RE)Forest Devices, Inc.K243185REMI Remote EEG Monitoring SystemEpitelK242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K232779QUEX ED; QUEX SQx World, 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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