Polytech Filter 100757EN
by Polytechnic Resources, Inc.
Polytech Filter 100757EN is a pulmonary function testing kit (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Polytechnic Resources, Inc., cleared under FDA 510(k) K042758 on 29 Aug 2005 and listed in FDA GUDID since 4 Nov 2016 (UDI-DI B446100757EN1), active as of 23 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 | NumberB446100757EN1 | Date4 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK042758 | Date29 Aug 2005 | StatusActive |
Official records
- FDA 510(k) database K042758
Across registries
- FDA 510(k) K042758 decided 29 Aug 2005 Active
- FDA GUDID UDI-DI B446100757EN1 listed 4 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K042758
- Listed FDA GUDID B446100757EN1
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Polytech Filter
- Generic name
- Pulmonary function testing kit
- Model / reference
- 100757EN
- Primary DI / UDI-DI
- B446100757EN1
- 510(k) Number
- FDA product code
- BZG
- GMDN term
- Pulmonary function testing kit
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 34.3 Millimeter
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