Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

HEARTCHECK ECG PEN WITH GEMS HOME

K-Number: K121009 · 2012-05-17

ApplicantCardiocomm Solutions, Inc.
Decision Date2012-05-17
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEARTCHECK ECG PEN 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 2012-05-17 under 510(k) number K121009. 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 ECG PEN WITH GEMS HOME?

HEARTCHECK ECG PEN WITH GEMS HOME is a medical device that received FDA 510(k) clearance on 2012-05-17. The listed applicant is Cardiocomm Solutions, Inc.. The 510(k) number is K121009.

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

HEARTCHECK ECG PEN WITH GEMS HOME received FDA 510(k) clearance on 2012-05-17, under 510(k) number K121009.

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

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

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 MobileK111159HEARTCHECK PEN HANDHELD ECG WITH GEMS HOMEK111320GLOBALCARDIOK033037MODIFICATION TO GLOBALCARDIOK022297GLOBAL ECG MANAGEMENT SYSTEM (GEMS)K020366GLOBAL ECG MANAGEMENT SYSTEM (GEMS)

View all 8 devices →

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.

↑