510(k) K831778
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1983
- Date Received
- June 2, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type