FDA.reportPublic FDA data

Cardio Q50, Cardio Q70

Primary DI
08809276944276
Brand
Cardio Q50, Cardio Q70
Company
Bionet CO,LTD
Model
CardioExpress 5012
Device description
Electrocardiographs and Spirometers
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

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic
DPSElectrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2
DPSElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231160000Cardio Q50, Cardio Q70Bionet Co., Ltd.2023-12-15DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809276944276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809276944276088092769442768809276944276

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometer, professionalAn electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.

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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809276943958Cardio Q50, Cardio Q70Cardio Q502026-05-26
08809276943965Cardio Q50, Cardio Q70Cardio Q702026-05-26
08809276943972Cardio P1Cardio P12026-05-26
08809276944269Cardio Q50, Cardio Q70CardioExpress 40122026-05-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943958Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
08809276943965Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276943972Cardio P1Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDDPS2026-05-26
08809276944269Cardio Q50, Cardio Q70Bionet CO,LTDBZG2026-05-26
03830059852216MESI mTABLET SPIROMESI d.o.o.BZG2026-03-24
00884838117358patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-05
00884838117273patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117280patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117297patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117303patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117310patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117327patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117334patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00884838117341patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-03-04
00843997011006Radius VSMMASIMO CORPORATIONDPS2026-02-23
00843997016018Radius VSMMASIMO CORPORATIONDPS2026-02-23
00884838131958Cardiologs PlatformPHILIPS FRANCEDPS2026-02-16
00732094360363Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
00732094360370Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-02-03
G697100010010CloudHRV™ SystemInmedix, Inc.DPS2026-01-30
00198953107263MACGe Medical Systems Information Technologies, Inc.DPS2026-01-27
00884838117198patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117204patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117211patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117228patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-16
00884838117259patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15
00884838117266patient lead wirePhilips Medizin Systeme Böblingen GmbHDPS2026-01-15