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FDA 510(k)

DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST

K-Number: K860470 · 1986-04-30

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

Device Summary

DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST 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 K860470. 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 MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST?

DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST 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 K860470.

When did DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST receive FDA 510(k) clearance?

DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST received FDA 510(k) clearance on 1986-04-30, under 510(k) number K860470.

Who is the listed applicant for DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST?

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 MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST?

The FDA product code for DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST is DSI.

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Other records listing Del Mar Avionics as applicant

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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)

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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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