510(k) K862206
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1986
- Date Received
- June 10, 1986
- 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