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FDA 510(k)

HOLTER SCANNER

K-Number: K881488 · 1988-09-20

ApplicantCardiodata Corp.
Decision Date1988-09-20
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Cardiodata Corp.. It received FDA 510(k) clearance on 1988-09-20 under 510(k) number K881488. 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 HOLTER SCANNER?

HOLTER SCANNER is a medical device that received FDA 510(k) clearance on 1988-09-20. The listed applicant is Cardiodata Corp.. The 510(k) number is K881488.

When did HOLTER SCANNER receive FDA 510(k) clearance?

HOLTER SCANNER received FDA 510(k) clearance on 1988-09-20, under 510(k) number K881488.

Who is the listed applicant for HOLTER SCANNER?

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

What is the FDA product code for HOLTER SCANNER?

The FDA product code for HOLTER SCANNER is DSI.

Related Clinical Trials

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Other records listing Cardiodata Corp. 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.

K900607MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11K873337MODEL SSR1 HOLTER MONITORK860167PRODIGY AND PRODIGY PLUS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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