510(k) K881876
K881876 is an FDA 510(k) premarket notification submitted by Dyonics, Inc. for the device "DYNAMIC CRUCIATE TESTER". The FDA issued a decision of Substantially Equivalent on November 17, 1988. The device falls under product code LYH (Arthrometer), a Class I device regulated under 21 CFR 890.1615. Dyonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1988
- Date Received
- May 4, 1988
- 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