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FDA 510(k)

MODEL 9300 ELECTROCARDIOVALIDATOR

K-Number: K801830 · 1980-08-27

ApplicantDel Mar Avionics
Decision Date1980-08-27
Product CodeDSF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 9300 ELECTROCARDIOVALIDATOR is the device name listed in this FDA 510(k) record. The listed applicant is Del Mar Avionics. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801830. 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 MODEL 9300 ELECTROCARDIOVALIDATOR?

MODEL 9300 ELECTROCARDIOVALIDATOR is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Del Mar Avionics. The 510(k) number is K801830.

When did MODEL 9300 ELECTROCARDIOVALIDATOR receive FDA 510(k) clearance?

MODEL 9300 ELECTROCARDIOVALIDATOR received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801830.

Who is the listed applicant for MODEL 9300 ELECTROCARDIOVALIDATOR?

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

What is the FDA product code for MODEL 9300 ELECTROCARDIOVALIDATOR?

The FDA product code for MODEL 9300 ELECTROCARDIOVALIDATOR is DSF.

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Other records listing Del Mar Avionics 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.

K990027OMNICORDER, MODEL 464K971696SENTINEL RECORDER, MODELS 471/472K963174HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)K950020HOLTER PACERCORDER(R)K942653HOLTER SSR DIGICORDER(TM)K922221SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM

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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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