510(k) K943197
K943197 is an FDA 510(k) premarket notification submitted by Medmetric Corp. for the device "KT1000/S KNEE LIGAMENT ARTHROMETER". The FDA issued a decision of Substantially Equivalent on March 2, 1995. The device falls under product code LYH (Arthrometer), a Class I device regulated under 21 CFR 890.1615. Medmetric Corp. has at least 7 other 510(k) clearances on record.
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