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FDA 510(k)

CARDIO-3 CHANNEL ELECTROCARDIOGRAPH

K-Number: K850454 · 1985-03-01

ApplicantZimmer Elektromedizin GmbH
Decision Date1985-03-01
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-3 CHANNEL ELECTROCARDIOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Elektromedizin GmbH. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850454. 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 CARDIO-3 CHANNEL ELECTROCARDIOGRAPH?

CARDIO-3 CHANNEL ELECTROCARDIOGRAPH is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Zimmer Elektromedizin GmbH. The 510(k) number is K850454.

When did CARDIO-3 CHANNEL ELECTROCARDIOGRAPH receive FDA 510(k) clearance?

CARDIO-3 CHANNEL ELECTROCARDIOGRAPH received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850454.

Who is the listed applicant for CARDIO-3 CHANNEL ELECTROCARDIOGRAPH?

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

What is the FDA product code for CARDIO-3 CHANNEL ELECTROCARDIOGRAPH?

The FDA product code for CARDIO-3 CHANNEL ELECTROCARDIOGRAPH is DPS.

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Other records listing Zimmer Elektromedizin GmbH as applicant

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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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