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FDA 510(k)

WALTER GRAPHTEK

K-Number: K910972 · 1991-10-02

ApplicantInomed Medizintechnik GmbH
Decision Date1991-10-02
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WALTER GRAPHTEK is the device name listed in this FDA 510(k) record. The listed applicant is Inomed Medizintechnik GmbH. It received FDA 510(k) clearance on 1991-10-02 under 510(k) number K910972. 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 WALTER GRAPHTEK?

WALTER GRAPHTEK is a medical device that received FDA 510(k) clearance on 1991-10-02. The listed applicant is Inomed Medizintechnik GmbH. The 510(k) number is K910972.

When did WALTER GRAPHTEK receive FDA 510(k) clearance?

WALTER GRAPHTEK received FDA 510(k) clearance on 1991-10-02, under 510(k) number K910972.

Who is the listed applicant for WALTER GRAPHTEK?

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

What is the FDA product code for WALTER GRAPHTEK?

The FDA product code for WALTER GRAPHTEK is GWQ.

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Other records listing Inomed Medizintechnik GmbH as applicant

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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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