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FDA 510(k)

ACTA GENOS ELECTROCARDIOGRAPH

K-Number: K884800 · 1989-06-22

ApplicantParexel Intl. Corp.
Decision Date1989-06-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACTA GENOS ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Parexel Intl. Corp.. It received FDA 510(k) clearance on 1989-06-22 under 510(k) number K884800. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACTA GENOS ELECTROCARDIOGRAPH?

ACTA GENOS ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1989-06-22. The listed applicant is Parexel Intl. Corp.. The 510(k) number is K884800.

When did ACTA GENOS ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

ACTA GENOS ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1989-06-22, under 510(k) number K884800.

Who is the listed applicant for ACTA GENOS ELECTROCARDIOGRAPH?

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

What is the FDA product code for ACTA GENOS ELECTROCARDIOGRAPH?

The FDA product code for ACTA GENOS ELECTROCARDIOGRAPH is DPS.

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Other records listing Parexel Intl. Corp. as applicant

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K900385ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGEK904901L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUCK904902SMA 26 TRANSDUCERK862414FUJI CR IMAGING PLATEK864519PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)K862416FTI 100 MEDICAL THERMAL IMAGER

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Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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