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FDA 510(k)

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME

K-Number: K111159 · 2011-12-22

ApplicantCardiocomm Solutions, Inc.
Decision Date2011-12-22
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocomm Solutions, Inc.. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K111159. 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 HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME?

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K111159.

When did HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME receive FDA 510(k) clearance?

HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME received FDA 510(k) clearance on 2011-12-22, under 510(k) number K111159.

Who is the listed applicant for HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME?

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

What is the FDA product code for HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME?

The FDA product code for HEARTCHECK PEN HANDHELD ECG WITH GEMS HOME is DPS.

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Other records listing Cardiocomm Solutions, Inc. 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.

K181310HeartCheck Cardi Beat ECG Monitor with GEMS MobileK121009HEARTCHECK ECG PEN WITH GEMS HOMEK111320GLOBALCARDIOK033037MODIFICATION TO GLOBALCARDIOK022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

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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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