510(k) K052176
K052176 is an FDA 510(k) premarket notification submitted by Zan Messgerate GmbH for the device "FLOWHANDY ZAN100 USB". The FDA issued a decision of Substantially Equivalent on January 12, 2006. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Zan Messgerate GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2006
- Date Received
- August 10, 2005
- 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