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FDA 510(k)

PAPER CHART RECORDER

K-Number: K811254 · 1981-07-10

ApplicantAmerican Edwards Laboratories
Decision Date1981-07-10
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PAPER CHART RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811254. 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 PAPER CHART RECORDER?

PAPER CHART RECORDER is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is American Edwards Laboratories. The 510(k) number is K811254.

When did PAPER CHART RECORDER receive FDA 510(k) clearance?

PAPER CHART RECORDER received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811254.

Who is the listed applicant for PAPER CHART RECORDER?

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

What is the FDA product code for PAPER CHART RECORDER?

The FDA product code for PAPER CHART RECORDER is DSF.

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Other records listing American Edwards Laboratories 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: 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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