pNeuton S
pNeuton S (20002) is a Class II device made by Airon Corporation, cleared under FDA 510(k) K024344 on 3 Jun 2003 and listed in FDA GUDID since 23 Oct 2015 (UDI-DI 00853678006016), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00853678006016 | Date23 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK024344 | Date3 Jun 2003 | StatusActive |
Official records
- AccessGUDID record 00853678006016
- FDA 510(k) database K024344
Across registries
- FDA 510(k) K024344 decided 3 Jun 2003 Active
- FDA GUDID UDI-DI 00853678006016 listed 23 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K024344
- Listed FDA GUDID 00853678006016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- pNeuton
- Generic name
- Portable pneumatic ventilator
- Model / Ref / Catalog
- S, 20002
- Primary DI / UDI-DI
- 00853678006016
- 510(k) Number
- FDA product code
- CBK
- GMDN term
- Portable pneumatic ventilator
- Device class
- Class II
- Regulation number
- 868.5895
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Weight — 6 PoundDepth — 6.5 InchWidth — 9.0 InchHeight — 4.0 Inch
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