510(k) K161536
K161536 is an FDA 510(k) premarket notification submitted by Ndd Medizintechnik AG for the device "EasyOne Air Spirometer". The FDA issued a decision of Substantially Equivalent on January 5, 2017. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Ndd Medizintechnik AG has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2017
- Date Received
- June 3, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type