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FDA 510(k)

CRITIKON DUAL CHANNEL RECORDER

K-Number: K792105 · 1979-10-26

ApplicantCritikon Company, LLC
Decision Date1979-10-26
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CRITIKON DUAL CHANNEL RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Critikon Company, LLC. It received FDA 510(k) clearance on 1979-10-26 under 510(k) number K792105. 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 CRITIKON DUAL CHANNEL RECORDER?

CRITIKON DUAL CHANNEL RECORDER is a medical device that received FDA 510(k) clearance on 1979-10-26. The listed applicant is Critikon Company, LLC. The 510(k) number is K792105.

When did CRITIKON DUAL CHANNEL RECORDER receive FDA 510(k) clearance?

CRITIKON DUAL CHANNEL RECORDER received FDA 510(k) clearance on 1979-10-26, under 510(k) number K792105.

Who is the listed applicant for CRITIKON DUAL CHANNEL RECORDER?

The FDA 510(k) record lists Critikon Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRITIKON DUAL CHANNEL RECORDER?

The FDA product code for CRITIKON DUAL CHANNEL RECORDER is DSF.

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Other records listing Critikon Company, LLC as applicant

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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

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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