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FDA 510(k)

KENL-ECG-3

K-Number: K811949 · 1981-08-13

ApplicantSuzuken Co., Ltd.
Decision Date1981-08-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KENL-ECG-3 is the device name listed in this FDA 510(k) record. The listed applicant is Suzuken Co., Ltd.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K811949. 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 KENL-ECG-3?

KENL-ECG-3 is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Suzuken Co., Ltd.. The 510(k) number is K811949.

When did KENL-ECG-3 receive FDA 510(k) clearance?

KENL-ECG-3 received FDA 510(k) clearance on 1981-08-13, under 510(k) number K811949.

Who is the listed applicant for KENL-ECG-3?

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

What is the FDA product code for KENL-ECG-3?

The FDA product code for KENL-ECG-3 is DPS.

Other records listing Suzuken Co., Ltd. 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.

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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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