F&P ICON SERIES CPAP— 510(k) K094040
Substantially EquivalentFisher & Paykel Healthcare, Ltd.
FDA 510(k) clearance K094040 for F&P ICON SERIES CPAP, Substantially Equivalent on 2010-04-27. Applicant: Fisher & Paykel Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Healthcare, Ltd.
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Tamaki, Auckland, NZ
Recent devices under product code BZD
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view all- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- 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
Adverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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 →
Recalls naming K094040
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K094040.
Data sourced from openFDA. This site is unofficial and independent of the FDA.