Aero-Sat 301-414
by Engineered Medical Systems, LLC
Aero-Sat 301-414 is a Class II device made by Engineered Medical Systems, LLC, cleared under FDA 510(k) K013122 on 19 Apr 2002 and listed in FDA GUDID since 11 Dec 2023 (UDI-DI 00841470103453), 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 | Number00841470103453 | Date11 Dec 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK013122 | Date19 Apr 2002 | StatusActive |
Official records
- AccessGUDID record 00841470103453
- FDA 510(k) database K013122
Across registries
- FDA 510(k) K013122 decided 19 Apr 2002 Active
- FDA GUDID UDI-DI 00841470103453 listed 11 Dec 2023 Listed
Timeline
- Cleared FDA 510(k) K013122
- Listed FDA GUDID 00841470103453
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aero-Sat
- Generic name
- Heat/moisture exchanger/microbial medical gas filter
- Model / reference
- 301-414
- Primary DI / UDI-DI
- 00841470103453
- 510(k) Number
- FDA product code
- CAH
- GMDN term
- Heat/moisture exchanger/microbial medical gas filter
- Device class
- Class II
- Regulation number
- 868.5260
- GUDID distribution status
- In Commercial Distribution
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