Device |
active noise attenuation system for infant incubators |
Definition |
A device system which captures the environmental noise and outputs noise cancelling acoustic sound waves to attenuate noise in infant incubators in the healthcare environment. |
Physical State |
The device may contain a noise sensor, a control or processing unit, and speakers. |
Technical Method |
The device captures environmental noise and utilizes a software algorithm that calculates the sound waves necessary to attenuate this noise. A speaker system subsequently outputs the corresponding sound wave inside the infant incubator, attenuating the noise. |
Target Area |
Whole Body |
Regulation Medical Specialty |
General Hospital |
Review Panel |
General Hospital |
Product Code | QWX |
Premarket Review |
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors
(DHT3C)
|
Submission Type |
510(k)
|
Regulation Number |
880.5405
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |