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FDA 510(k)

ELECTROCARDIOGRAPH, MODEL ECG-5151

K-Number: K792229 · 1979-11-21

ApplicantNihon Kohden America, Inc.
Decision Date1979-11-21
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH, MODEL ECG-5151 is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1979-11-21 under 510(k) number K792229. 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 ELECTROCARDIOGRAPH, MODEL ECG-5151?

ELECTROCARDIOGRAPH, MODEL ECG-5151 is a medical device that received FDA 510(k) clearance on 1979-11-21. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K792229.

When did ELECTROCARDIOGRAPH, MODEL ECG-5151 receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH, MODEL ECG-5151 received FDA 510(k) clearance on 1979-11-21, under 510(k) number K792229.

Who is the listed applicant for ELECTROCARDIOGRAPH, MODEL ECG-5151?

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

What is the FDA product code for ELECTROCARDIOGRAPH, MODEL ECG-5151?

The FDA product code for ELECTROCARDIOGRAPH, MODEL ECG-5151 is DPS.

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Other records listing Nihon Kohden America, Inc. 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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