510(k) K092890
K092890 is an FDA 510(k) premarket notification submitted by Carefusion Germany 234 GmbH for the device "ASTHMA MONITOR AM3". The FDA issued a decision of Substantially Equivalent on January 13, 2010. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Carefusion Germany 234 GmbH has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2010
- Date Received
- September 21, 2009
- Clearance Type
- Special
- 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