510(k) K090486
K090486 is an FDA 510(k) premarket notification submitted by Cardinal Health Germany 234 GmbH for the device "ASTHMA MONITOR MODEL, AM1". The FDA issued a decision of Substantially Equivalent on May 6, 2009. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Cardinal Health Germany 234 GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2009
- Date Received
- February 25, 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