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FDA 510(k)

MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM

K-Number: K891148 · 1989-05-11

ApplicantDel Mar Avionics
Decision Date1989-05-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM 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 1989-05-11 under 510(k) number K891148. 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 MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM?

MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Del Mar Avionics. The 510(k) number is K891148.

When did MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM receive FDA 510(k) clearance?

MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM received FDA 510(k) clearance on 1989-05-11, under 510(k) number K891148.

Who is the listed applicant for MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM?

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 152 DELTA HOLTER ECG ANALYSIS SYSTEM?

The FDA product code for MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM 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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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