510(k) K111764
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2011
- Date Received
- June 23, 2011
- 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