Device |
monitor, apnea, facility use |
Regulation Description |
Apnea monitor. |
Regulation Medical Specialty |
Anesthesiology |
Review Panel |
Anesthesiology |
Product Code | FLS |
Premarket Review |
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
Division of Anesthesia, Respiratory, and Sleep Devices
(DHT1C)
|
Submission Type |
510(k)
|
Regulation Number |
868.2377
|
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
|
Guidance Document
|
Third Party Review |
Not Third Party Eligible |
|
|