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FDA 510(k)

TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY

K-Number: K010505 · 2001-03-09

ApplicantBrentwood Medical Technology Corp.
Decision Date2001-03-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TELEMED 12 LEAD RESTING ECG ANALYSIS 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 2001-03-09 under 510(k) number K010505. 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 TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY?

TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY is a medical device that received FDA 510(k) clearance on 2001-03-09. The listed applicant is Brentwood Medical Technology Corp.. The 510(k) number is K010505.

When did TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY receive FDA 510(k) clearance?

TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY received FDA 510(k) clearance on 2001-03-09, under 510(k) number K010505.

Who is the listed applicant for TELEMED 12 LEAD RESTING ECG ANALYSIS 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 TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY?

The FDA product code for TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY is DPS.

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Other records listing Brentwood Medical Technology Corp. as applicant

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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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