Wearable Biosensor
CorVitals - CV1253
Device Description
A 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.
Environmental Conditions
- 90.00
- 10.00
- 45.00
- 0.00
- For long-term storage of more than 30 days, maintain between 10 and 27 Degrees Celsius
- 90.00
- 10.00
- 45.00
- 0.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DRG
Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2910
Third Party Flag: Y
Medical Specialty: CV
Code: MWJ
Device Name: Electrocardiograph, Ambulatory (Without Analysis)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.2800
Third Party Flag: N
Medical Specialty: CV
Code: MHX
Device Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1025
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: B353CV12532
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B353CV12531
Package Quantity: 25
Package Discontinue Date: 1/31/2025 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Small Box
Device Id: B353CV12531
Device Type: Primary
DeviceId Issuing Agency: HIBCC
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: B353CV12533
Device Type: Package
DeviceId Issuing Agency: HIBCC
Contains DI Number: B353CV12532
Package Quantity: 8
Package Discontinue Date: 1/31/2025 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Big Box
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