KT1000/S Knee Ligament Arthrometer
FDA 510(k) K943197 · Medmetric Corp.
510(k) numberK943197
Submission
- Device name
- KT1000/S Knee Ligament Arthrometer
- Applicant
- Medmetric Corp.
San Diego, CA, US - Received
- July 5, 1994
- Decision date
- March 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LYH – Arthrometer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.1615
- Specialty
- Physical Medicine
Other 510(k)s with product code LYH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942059 | KT2000 Knee Ligament ArthrometerLYH · Traditional | Medmetric Corp. | 09/20/1994SE |
| K881876 | Dynamic Cruciate TesterLYH · Traditional | Dyonics, Inc. | 11/17/1988SE |
| K834462 | GenucomLYH · Traditional | Far Orthopedics, Inc. | 02/09/1984SE |
| K812806 | KT-1000 DeviceLYH · Traditional | Medmetric Corp. | 11/10/1981SE |
More from Medmetric Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K942059 | KT2000 Knee Ligament ArthrometerLYH · Traditional | 09/20/1994SE |
| K904823 | FlexercycleISD · Traditional | 01/30/1991SE |
| K904898 | Torque Frame QTF1000IKK · Traditional | 11/28/1990SE |
| K854254 | Tension-IsometerLXI · Traditional | 11/15/1985SE |
| K812806 | KT-1000 DeviceLYH · Traditional | 11/10/1981SE |
| K812713 | Drawer TestFTY · Traditional | 11/05/1981SE |
| K801572 | Surg-AssistFWZ · Traditional | 08/04/1980SE |
Questions and answers
When was KT1000/S Knee Ligament Arthrometer cleared by the FDA?
KT1000/S Knee Ligament Arthrometer (K943197) received a 510(k) decision of Substantially Equivalent on March 2, 1995, 240 days after the submission was received.
What is the product code of K943197?
The FDA product code is LYH – Arthrometer, a Class I (low risk) device regulated under 21 CFR 890.1615.