510(k) K100687
K100687 is an FDA 510(k) premarket notification submitted by Vitalograph (Ireland) , Ltd. for the device "VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120". The FDA issued a decision of Substantially Equivalent on Oct 16, 2010. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Vitalograph (Ireland) , Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 16, 2010
- Date Received
- Mar 10, 2010
- 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