510(k) K880550
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 1988
- Date Received
- February 9, 1988
- 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