End Expiratory Filter, Model RT020
by Fisher & Paykel Healthcare, Inc.
510(k) K002839
End Expiratory Filter, Model RT020 is a medical device (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by Fisher & Paykel Healthcare, Inc., cleared under FDA 510(k) K002839 on 4 Oct 2001, 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 | NumberK002839 | Date4 Oct 2001 | StatusActive |
Official records
- FDA 510(k) database K002839
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CAH
- FDA applicant
- Fisher & Paykel Healthcare, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.5260
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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