510(k) K831586
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1984
- Date Received
- May 17, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Pulmonary Function Interpretor (Diagnostic)
- Device Class
- Class II
- Regulation Number
- 868.1900
- Review Panel
- AN
- Submission Type