Device |
system, network and communication, physiological monitors |
Regulation Description |
Cardiac monitor (including cardiotachometer and rate alarm). |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | MSX |
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? |
Yes
|
Recognized Consensus Standards
|
Third Party Review |
Not Third Party Eligible |
|
|