HUMIDIFIER & ACCESSORIES— 510(k) K953949
Substantially EquivalentFisher & Paykel Electronics , Ltd.
FDA 510(k) clearance K953949 for HUMIDIFIER & ACCESSORIES, Substantially Equivalent on 1995-10-16. Applicant: Fisher & Paykel Electronics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Electronics , Ltd.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, New Zealand, NZ
Recent devices under product code CAW
view allMore clearances from Fisher & Paykel Electronics , Ltd.
view all- K973161 — CPAP HUMIDIFIER (HC 200)
- K972885 — SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
- K971695 — SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
- K971461 — SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
- K970432 — INFANT RADIANT WARMER - MODELS IW910 AND IW920
Adverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
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.