510(k) K832209
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1983
- Date Received
- July 7, 1983
- 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