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FDA 510(k)

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)

K-Number: K960449 · 1996-05-30

ApplicantBiosensor Corp.
Decision Date1996-05-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) is the device name listed in this FDA 510(k) record. The listed applicant is Biosensor Corp.. It received FDA 510(k) clearance on 1996-05-30 under 510(k) number K960449. 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 PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)?

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) is a medical device that received FDA 510(k) clearance on 1996-05-30. The listed applicant is Biosensor Corp.. The 510(k) number is K960449.

When did PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) receive FDA 510(k) clearance?

PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) received FDA 510(k) clearance on 1996-05-30, under 510(k) number K960449.

Who is the listed applicant for PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)?

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

What is the FDA product code for PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90)?

The FDA product code for PC ECG 1200 ECG AND STRESS ELECTROCARDIOGRAPHY TESTING SYSTEM(VERSION 2.90) is DPS.

Related Clinical Trials

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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Other records listing Biosensor Corp. 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.

K990956BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005K974546BIOSENSOR HOLTER MONITOR SYSTEMK974192BIOSENSOR HOLTER MONITOR SYSTEMK950944AMBULATORY (HOLTER) RECORDING SYSTEMK943338BIOSENSOR BIDOP VASCULAR TEST SYSTEMK950723AMBULATORY (HOLTER) RECORDING SYSTEM

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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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