END EXPIRATORY FILTER, MODEL RT020
FDA 510(k) clearance K002839 · decided 2001-10-04
Clearance details
- K-number
- K002839
- Device name
- END EXPIRATORY FILTER, MODEL RT020
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-12
- Decision date
- 2001-10-04
- Days to decision
- 387 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- East Tamaki, Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.