510(k) K090034
K090034 is an FDA 510(k) premarket notification submitted by Ndd Medizitechnik AG for the device "EASY ON-PC SPIROMETER". The FDA issued a decision of Substantially Equivalent on June 2, 2009. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Ndd Medizitechnik AG has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2009
- Date Received
- January 6, 2009
- 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