Enteral Only Extension Set
510(k) K082654
Enteral Only Extension Set is a Class II device made by Respironics Inc., cleared under FDA 510(k) K082654 on 25 Nov 2008, 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 | FDA 510(k)SESE | NumberK082654 | Date25 Nov 2008 | StatusActive |
Official records
- FDA 510(k) database K082654
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KNT
- FDA applicant
- Respironics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
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