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FDA 510(k)

WR3500 AND WR3600 SERIES RECORDERS

K-Number: K894922 · 1990-01-26

ApplicantWestern Graphtec
Decision Date1990-01-26
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WR3500 AND WR3600 SERIES RECORDERS is the device name listed in this FDA 510(k) record. The listed applicant is Western Graphtec. It received FDA 510(k) clearance on 1990-01-26 under 510(k) number K894922. The device is classified under product code DSF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WR3500 AND WR3600 SERIES RECORDERS?

WR3500 AND WR3600 SERIES RECORDERS is a medical device that received FDA 510(k) clearance on 1990-01-26. The listed applicant is Western Graphtec. The 510(k) number is K894922.

When did WR3500 AND WR3600 SERIES RECORDERS receive FDA 510(k) clearance?

WR3500 AND WR3600 SERIES RECORDERS received FDA 510(k) clearance on 1990-01-26, under 510(k) number K894922.

Who is the listed applicant for WR3500 AND WR3600 SERIES RECORDERS?

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

What is the FDA product code for WR3500 AND WR3600 SERIES RECORDERS?

The FDA product code for WR3500 AND WR3600 SERIES RECORDERS is DSF.

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Related Devices (Code: DSF)

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.

K910871EDENTEC DIGITAL CHARTER MODEL 3710Edentec Corp.K912929DASH IVAstro-Med, Inc.K905856MODEL 556 MONITORGe Medical Systems Information TechnologiesK902586GRI LASERGRAPH(TM) ECG PAPERGri Medical Products, Inc.K902230COLORADO COLOR IMAGING RECORDERHoneywell, Inc.K901385GABRIEL MEDICAL CLS THERMAL RECORDERGabriel Medical, 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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