EasyOne Pro Respiratory Analysis System— 510(k) K161534
Substantially EquivalentNdd Medizintechnik AG
FDA 510(k) clearance K161534 for EasyOne Pro Respiratory Analysis System, Substantially Equivalent on 2017-02-22. Applicant: Ndd Medizintechnik AG. Device class: 2.
Clearance details
- Applicant
- Ndd Medizintechnik AG
- Product code
- Code BTY
- Device class
- Class 2
- Regulation
- 21 CFR 868.1890
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zurich, CH
Recent devices under product code BTY
view allMore clearances from Ndd Medizintechnik AG
view allRecalls naming K161534
K-number listed on FDA's recall record- Z-0596-2020 — EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
- Z-0597-2020 — EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161534.
Data sourced from openFDA. This site is unofficial and independent of the FDA.