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FDA 510(k)

MOBILEECG SYSTEM

K-Number: K103427 · 2011-03-24

ApplicantMemtec Corp.
Decision Date2011-03-24
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MOBILEECG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Memtec Corp.. It received FDA 510(k) clearance on 2011-03-24 under 510(k) number K103427. 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 MOBILEECG SYSTEM?

MOBILEECG SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-24. The listed applicant is Memtec Corp.. The 510(k) number is K103427.

When did MOBILEECG SYSTEM receive FDA 510(k) clearance?

MOBILEECG SYSTEM received FDA 510(k) clearance on 2011-03-24, under 510(k) number K103427.

Who is the listed applicant for MOBILEECG SYSTEM?

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

What is the FDA product code for MOBILEECG SYSTEM?

The FDA product code for MOBILEECG SYSTEM 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 Memtec 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.

K102723MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSISK944180MODEL 700

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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