RT016 INSPIRATORY FILTER— 510(k) K133666
Substantially EquivalentFisher & Paykel Healthcare, Ltd.
FDA 510(k) clearance K133666 for RT016 INSPIRATORY FILTER, Substantially Equivalent on 2014-02-05. Applicant: Fisher & Paykel Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
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Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.