510(k) K161534
K161534 is an FDA 510(k) premarket notification submitted by Ndd Medizintechnik AG for the device "EasyOne Pro Respiratory Analysis System". The FDA issued a decision of Substantially Equivalent on February 22, 2017. The device falls under product code BTY (Calculator, Predicted Values, Pulmonary Function), a Class II device regulated under 21 CFR 868.1890. Ndd Medizintechnik AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2017
- Date Received
- June 3, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Predicted Values, Pulmonary Function
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- AN
- Submission Type