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FDA 510(k)

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)

K-Number: K963578 · 1997-06-30

ApplicantIntl. Products, Inc.
Decision Date1997-06-30
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Products, Inc.. It received FDA 510(k) clearance on 1997-06-30 under 510(k) number K963578. 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 BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)?

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) is a medical device that received FDA 510(k) clearance on 1997-06-30. The listed applicant is Intl. Products, Inc.. The 510(k) number is K963578.

When did PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) receive FDA 510(k) clearance?

PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) received FDA 510(k) clearance on 1997-06-30, under 510(k) number K963578.

Who is the listed applicant for PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)?

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

What is the FDA product code for PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)?

The FDA product code for PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG) 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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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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