AirFit N20— 510(k) K161978
Substantially EquivalentResmed, Ltd.
FDA 510(k) clearance K161978 for AirFit N20, Substantially Equivalent on 2016-11-17. Applicant: Resmed, Ltd.. Device class: 2.
Clearance details
- Applicant
- Resmed, 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
- Bella Vista, AU
Recent devices under product code BZD
view allMore clearances from Resmed, Ltd.
view allAdverse 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 K161978
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 K161978.
Data sourced from openFDA. This site is unofficial and independent of the FDA.