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FDA 510(k)

MIDMARK IQECG

K-Number: K103640 · 2011-03-22

ApplicantBrentwood Medical Technology Corp.
Decision Date2011-03-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MIDMARK IQECG 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 2011-03-22 under 510(k) number K103640. 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 MIDMARK IQECG?

MIDMARK IQECG is a medical device that received FDA 510(k) clearance on 2011-03-22. The listed applicant is Brentwood Medical Technology Corp.. The 510(k) number is K103640.

When did MIDMARK IQECG receive FDA 510(k) clearance?

MIDMARK IQECG received FDA 510(k) clearance on 2011-03-22, under 510(k) number K103640.

Who is the listed applicant for MIDMARK IQECG?

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 MIDMARK IQECG?

The FDA product code for MIDMARK IQECG 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.

K100913IQVITALS AND IQVITALS SYSTEMK052898IQMARK EZ STRESSK031466IQMARK DIGITAL HOLTERK013717BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARYK010505TELEMED 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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