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U.S. Department of Health and Human Services

Product Classification
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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 CodeQWX
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
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