FDA.reportPublic FDA data

Corsano CardioWatch 287-2 System

Primary DI
08720256776529
Brand
Corsano CardioWatch 287-2 System
Company
Corsano Health B.V.
Model
CardioWatch 287-2
Catalog number
CW287-2
Device description
Corsano Health Wearable Monitoring System
Published
2024-06-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic
BZQMonitor, Breathing Frequency
DQAOximeter
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
DXNSystem, Measurement, Blood-Pressure, Non-Invasive
FLLThermometer, Electronic, Clinical
FRIScale, Stand-On, Patient
MSXSystem, Network And Communication, Physiological Monitors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2
BZQMonitor, Breathing FrequencyAnesthesiology2
DQAOximeterCardiovascular2
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
FRIScale, Stand-On, PatientGeneral Hospital1
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232548000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232548000Corsano CardioWatch 287-2 SystemCorsano Health B.V.2024-03-22MSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720256776529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720256776529087202567765298720256776529

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Regulatory Flags#

DUNS number
493148003
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
08720256776567Corsano CardioWatch 287-2 SystemCardioWatch 287-2-SBLCW287-2-SBL2026-06-02
08720256776659Strap Silicon BlueStrap Silicon BlueCS-SBL2026-06-02
08720256776987Charge Station 10 Sensors ACharge Station 10 Sensors ACS-CHARGE10-A2026-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
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06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
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