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FDA 510(k)

BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY

K-Number: K013717 · 2002-02-06

ApplicantBrentwood Medical Technology Corp.
Decision Date2002-02-06
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Medical Technology Corp.. It received FDA 510(k) clearance on 2002-02-06 under 510(k) number K013717. 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 BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY?

BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY is a medical device that received FDA 510(k) clearance on 2002-02-06. The listed applicant is Brentwood Medical Technology Corp.. The 510(k) number is K013717.

When did BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY receive FDA 510(k) clearance?

BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY received FDA 510(k) clearance on 2002-02-06, under 510(k) number K013717.

Who is the listed applicant for BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY?

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

What is the FDA product code for BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY?

The FDA product code for BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY is DPS.

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Other records listing Brentwood Medical Technology 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.

K103640MIDMARK IQECGK100913IQVITALS AND IQVITALS SYSTEMK052898IQMARK EZ STRESSK031466IQMARK DIGITAL HOLTERK010505TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARYK002499BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

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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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