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FDA 510(k)

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG

K-Number: K093223 · 2010-01-15

ApplicantCompumedics Limited
Decision Date2010-01-15
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2010-01-15 under 510(k) number K093223. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG?

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG is a medical device that received FDA 510(k) clearance on 2010-01-15. The listed applicant is Compumedics Limited. The 510(k) number is K093223.

When did COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG receive FDA 510(k) clearance?

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG received FDA 510(k) clearance on 2010-01-15, under 510(k) number K093223.

Who is the listed applicant for COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG?

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

What is the FDA product code for COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG?

The FDA product code for COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG is GWQ.

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Other records listing Compumedics Limited 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.

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Related Devices (Code: GWQ)

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.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, 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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