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FDA 510(k)

DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER

K-Number: K860471 · 1986-04-30

ApplicantDel Mar Avionics
Decision Date1986-04-30
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER 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 1986-04-30 under 510(k) number K860471. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER?

DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER is a medical device that received FDA 510(k) clearance on 1986-04-30. The listed applicant is Del Mar Avionics. The 510(k) number is K860471.

When did DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER receive FDA 510(k) clearance?

DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER received FDA 510(k) clearance on 1986-04-30, under 510(k) number K860471.

Who is the listed applicant for DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER?

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 DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER?

The FDA product code for DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER is DSI.

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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: DSI)

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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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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