Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- OWPBiological Sterilization Process Indicator With Recombinant-Dna Plasmid2Product Code
- LLCContainer, Supplementary NitroglycerinUProduct Code
- LLDPort & Catheter, Implanted, Subcutaneous, IntraperitonealUProduct Code
- LMQDevice, Peritoneal Access, Subcutaneous, Implanted3Product Code
- LNXMedical Computers And SoftwareUProduct Code
- LNYCatheter, Percutaneous, Long Term, Intraspinal3Product Code
- LPZContainer, Frozen Donor Tissue StorageUProduct Code
- LSXController, Closed-Loop, Blood-Pressure3Product Code
- QKYDecontamination Systems For N95 RespiratorsNProduct Code
- LDHSystem, Delivery, Allergen And VaccineUProduct Code
- LKBPad, Alcohol, Device DisinfectantUProduct Code
- LKKPump, Infusion, Implanted, Programmable3Product Code
- LWEBone Marrow Collection/Transfusion Kit2Product Code
- MQTPump, Drug Administration, Closed Loop3Product Code
- NSXSoftware, Transmission And Storage, Patient DataUProduct Code
- PGOAnti-Stick Glass SyringeNProduct Code
- POTLockbox (Export Only)NProduct Code
- PWCGeneral Wellness ProductUProduct Code
- QBPCap, Device DisinfectantUProduct Code
- QIXSystem, Transdermal Delivery, Cder Or Cber LedNProduct Code
- QIYNasal Spray, Systemic Delivery, Cder Or Cber LedNProduct Code
- QIZMaterial, Implantable For Controlled Release, Cder Or Cber LedNProduct Code
- QKRFace Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health EmergencyNProduct Code
- QKUNon-Niosh-Approved Disposable Filtering Facepiece Respirators (Ffrs)NProduct Code
- QLDProtective Barrier EnclosureNProduct Code
- QLEProtective Barrier Enclosure With Negative PressureNProduct Code
- QMFMask, Surgical, Eua AuthorizedNProduct Code
- QOZBarrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health EmergencyNProduct Code
- QJTRigid Sterilization Container With Software2Product Code
- QTGInfant Supine Sleep System2Product Code
- QWSFoam Or Gel Chemical Sterilant/High Level Disinfectant2Product Code
- QWXActive Noise Attenuation System For Infant Incubators2Product Code
- QXJWhole Room Microbial Reduction Device2Product Code
- QZABody Temperature Sensing Software2Product Code
- QPKEua FaceshieldsNProduct Code
- QZTGowns And Other ApparelNProduct Code
- SBEDigital Physical/Chemical Sterilization Process Sensor2Product Code
- QVBBiological Sterilization Indicator With Indirect Growth Detection2Product Code
- QXQRespiratory Accessory Microbial Reduction Device.2Product Code
- SCSUltraviolet Radiation Disinfection Chamber Device2Product Code
- SDCQualitative Cleaning Process Protein Indicator2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
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- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Active Noise Attenuation System For Infant Incubators
- Page Type
- Product Code
- 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
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 880.5405
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QWX is linked to regulation 21CFR880.5405, which does not seem to exist yet. It may be pending at the moment.