QWXClass II
Active Noise Attenuation System For Infant Incubators
21 CFR 880.5405 / General Hospital
QWX is the FDA product code for Active Noise Attenuation System For Infant Incubators, a class II device type, regulated under 21 CFR 880.5405. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QWX
- Device name
- Active Noise Attenuation System For Infant Incubators
- FDA 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.
- Regulation
- 21 CFR 880.5405
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QWX
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2023 | 1 |
Applicants with the most clearances
Product code QWX| Applicant | Clearances |
|---|---|
| Invictus Medical, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code QWX.
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