510(k) K972086
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1997
- Date Received
- June 4, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Monitoring (W/Wo Alarm)
- Device Class
- Class II
- Regulation Number
- 868.1850
- Review Panel
- AN
- Submission Type