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FDA 510(k)

CRYSTAL-EEG MODEL 10 (MODEL 10)

K-Number: K970672 · 1997-05-22

ApplicantCleveland Medical Devices, Inc.
Decision Date1997-05-22
Product CodeOMC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRYSTAL-EEG MODEL 10 (MODEL 10) is the device name listed in this FDA 510(k) record. The listed applicant is Cleveland Medical Devices, Inc.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K970672. 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 CRYSTAL-EEG MODEL 10 (MODEL 10)?

CRYSTAL-EEG MODEL 10 (MODEL 10) is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Cleveland Medical Devices, Inc.. The 510(k) number is K970672.

When did CRYSTAL-EEG MODEL 10 (MODEL 10) receive FDA 510(k) clearance?

CRYSTAL-EEG MODEL 10 (MODEL 10) received FDA 510(k) clearance on 1997-05-22, under 510(k) number K970672.

Who is the listed applicant for CRYSTAL-EEG MODEL 10 (MODEL 10)?

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

What is the FDA product code for CRYSTAL-EEG MODEL 10 (MODEL 10)?

The FDA product code for CRYSTAL-EEG MODEL 10 (MODEL 10) is OMC.

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Other records listing Cleveland Medical Devices, 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.

K063872KINESIAK042039FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120K013863CRYSTAL MONITOR MODEL 16K001110CRYSTAL-EEG MODEL 15K964690LIBERTY VALVEK962591FOOT WEIGHT ALARM

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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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