FDA.report

Cardio P1

Primary DI
08809276943972
Brand
Cardio P1
Company
Bionet CO,LTD
Model
Cardio P1
Device description
Electrocardiograph
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DPSElectrocardiograph

Product Code Classifications

CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2

Premarket Submissions

SubmissionSupplement
K231150000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K231150000Cardio P1Bionet Co., Ltd.2023-11-09DPS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08809276943972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08809276943972088092769439728809276943972

GMDN Terms

TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Regulatory Flags

DUNS number
689708212
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08809276943958Cardio Q50, Cardio Q70Cardio Q502026-05-26
08809276943965Cardio Q50, Cardio Q70Cardio Q702026-05-26
08809276944269Cardio Q50, Cardio Q70CardioExpress 40122026-05-26
08809276944276Cardio Q50, Cardio Q70CardioExpress 50122026-05-26
18809276940282CardioXPCardioXP2021-07-15
18809276943535CardioCare2000CardioCare20002021-07-15
18809276943542CardioTouch3000CardioTouch30002021-07-15
18809276943559Cardio7Cardio72021-07-15
18809276943597FC700FC7002021-07-15
18809276943603FC1400FC14002021-07-15
18809276943641BM3/BM3 PlusBM3/BM3 Plus2021-07-15
18809276943726Spiro HandleSpiro Handle2021-07-15
08809276941480SPM-300110111-0100002016-09-12
08809276940469BM3/BM3 PLUS110327-0300502016-09-11
08809276940643BIONET BM3PLUS PATIENT MONITOR110307-0700002016-09-12

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08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944276Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
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