510(k) K160116
K160116 is an FDA 510(k) premarket notification submitted by Ganshorn Medizin Electronic GmbH for the device "SpiroScout". The FDA issued a decision of Substantially Equivalent on October 7, 2016. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Ganshorn Medizin Electronic GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2016
- Date Received
- January 19, 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