RT016 INSPIRATORY FILTER
FDA 510(k) clearance K133666 · decided 2014-02-05
Clearance details
- K-number
- K133666
- Device name
- RT016 INSPIRATORY FILTER
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2013-11-29
- Decision date
- 2014-02-05
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- CAH
- Device class
- 2
- Regulation number
- 868.5260
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Auckland, NZ
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.