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FDA 510(k)

BIOLOG 3000 ELECTROCARDIOGRAPH

K-Number: K974351 · 1998-04-01

ApplicantMicromedical, Inc.
Decision Date1998-04-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOLOG 3000 ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical, Inc.. It received FDA 510(k) clearance on 1998-04-01 under 510(k) number K974351. 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 BIOLOG 3000 ELECTROCARDIOGRAPH?

BIOLOG 3000 ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1998-04-01. The listed applicant is Micromedical, Inc.. The 510(k) number is K974351.

When did BIOLOG 3000 ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

BIOLOG 3000 ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1998-04-01, under 510(k) number K974351.

Who is the listed applicant for BIOLOG 3000 ELECTROCARDIOGRAPH?

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

What is the FDA product code for BIOLOG 3000 ELECTROCARDIOGRAPH?

The FDA product code for BIOLOG 3000 ELECTROCARDIOGRAPH is DPS.

Related Clinical Trials

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Other records listing Micromedical, Inc. 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.

K974352CARDIOVIEW 3000 SOFTWAREK974220MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK970305PRINTER INTERFACEK955891CARDIOVIEW TRANSTELEPHONIC SOFTWARE

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

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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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