ClearChest® 100104-000
by Respiratory Technologies, Inc.
ClearChest® 100104-000 is a Class II device made by Respiratory Technologies, Inc., cleared under FDA 510(k) K051383 on 17 Jun 2005 and listed in FDA GUDID since 10 Sep 2016 (UDI-DI 00841561102334), 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 | Number00841561102334 | Date10 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK051383 | Date17 Jun 2005 | StatusActive |
Official records
- AccessGUDID record 00841561102334
- FDA 510(k) database K051383
Across registries
- FDA 510(k) K051383 decided 17 Jun 2005 Active
- FDA GUDID UDI-DI 00841561102334 listed 10 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K051383
- Listed FDA GUDID 00841561102334
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ClearChest®
- Generic name
- Chest-oscillation airway secretion-clearing system vest
- Model / reference
- 100104-000
- Primary DI / UDI-DI
- 00841561102334
- 510(k) Number
- FDA product code
- BYI
- GMDN term
- Chest-oscillation airway secretion-clearing system vest
- Device class
- Class II
- Regulation number
- 868.5665
- GUDID distribution status
- In Commercial Distribution
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