510(k) K885292
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1989
- Date Received
- December 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator/Data Processing Module, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2100
- Review Panel
- CH
- Submission Type