FDA.reportPublic FDA data

HeartCheck Palm

Primary DI
00812324000136
Brand
HeartCheck Palm
Company
CardioComm Solutions, Inc
Model
HC-PM10
Catalog number
HC-PM10
Device description
HeartCheck Palm Portable ECG
Published
2017-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152863000Portable ECG MonitorContec Medical Systems Co.,Ltd2016-06-22DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812324000136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324000136008123240001368123240001360812324000136

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic monitorA mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251043907
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812324000297GEMS Mobile ECGGMGM2025-03-20
00812324000204GEMS Win ArrhythmiaGW-ARRGW-ARR2023-11-09
00812324000211GEMS Win TTMGW-TTMGW-TTM2023-11-09
00812324000242GEMS Win AutoAttendantGW-AAGW-AA2023-11-09
00812324000259GEMS Win AirGW-AIRGW-AIR2023-11-09
00812324000228GEMS Win TTM & ICDGW-TTMICDGW-TTMICD2023-11-08
00812324000266GEMS Win HL7GW-HL7GW-HL72023-11-08
00812324000020HeartCheck BT PEN Handheld ECGHCEKGBTPEN30HCEKGBTPEN302017-11-28
00812324000044HeartCheck CardiBeatHC-WC-01HC-WC-012019-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DPS2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
00810209880019CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response PinkEko Devices, Inc.DPS2026-04-03
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10843997011003Radius VSMMASIMO CORPORATIONDPS2026-02-23