510(k) K896202
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 2, 1990
- Date Received
- October 26, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Counter (Beta, Gamma) For Clinical Use
- Device Class
- Class I
- Regulation Number
- 862.2320
- Review Panel
- CH
- Submission Type