510(k) K943197
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 1995
- Date Received
- July 5, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthrometer
- Device Class
- Class I
- Regulation Number
- 890.1615
- Review Panel
- NE
- Submission Type