Device |
low patient acuity monitoring system |
Regulation Description |
Cardiac monitor (including cardiotachometer and rate alarm). |
Definition |
For non-continuous central monitoring of patient parameters, including cardiac parameters, in low risk patients. |
Physical State |
electronic software-driven monitor |
Technical Method |
Electronic display at a central monitoring station of monitoring data from patient sensors. |
Target Area |
involves cardiac sensing and other sensor locations on the body |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PFY |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
510(k)
|
Regulation Number |
870.2300
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review |
Not Third Party Eligible |