510(k) K033939
K033939 is an FDA 510(k) premarket notification submitted by Sdi Diagnostics, Inc. for the device "FLOSENSE II, MODEL 29-8040". The FDA issued a decision of Substantially Equivalent on January 30, 2004. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Sdi Diagnostics, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2004
- Date Received
- December 15, 2003
- 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