RESPIRATORY HUMIDIFER— 510(k) K110019
Substantially EquivalentFisher & Paykel Healthcare, Ltd.
FDA 510(k) clearance K110019 for RESPIRATORY HUMIDIFER, Substantially Equivalent on 2012-03-30. Applicant: Fisher & Paykel Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Auckland, NZ
Recent devices under product code BTT
view allMore clearances from Fisher & Paykel Healthcare, Ltd.
view all- K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more
- K243917 — F&P Optiflow Air/Oxygen Flow Source
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942) +5 more
- K233643 — F&P Airvo 3 NIV (PT311US)
Adverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.