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FDA 510(k)

ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST

K-Number: K914206 · 1992-03-30

ApplicantKardiosis Ltd. Co.
Decision Date1992-03-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST is the device name listed in this FDA 510(k) record. The listed applicant is Kardiosis Ltd. Co.. It received FDA 510(k) clearance on 1992-03-30 under 510(k) number K914206. 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 ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST?

ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST is a medical device that received FDA 510(k) clearance on 1992-03-30. The listed applicant is Kardiosis Ltd. Co.. The 510(k) number is K914206.

When did ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST receive FDA 510(k) clearance?

ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST received FDA 510(k) clearance on 1992-03-30, under 510(k) number K914206.

Who is the listed applicant for ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST?

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

What is the FDA product code for ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST?

The FDA product code for ARS-EKG 12K INTERPRETIVE ELECTROCARDIOGRAPHY SYST is DPS.

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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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