KT-1000 Device
FDA 510(k) K812806 · Medmetric Corp.
510(k) numberK812806
Submission
- Device name
- KT-1000 Device
- Applicant
- Medmetric Corp.
- Received
- October 6, 1981
- Decision date
- November 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K943197 | KT1000/S Knee Ligament ArthrometerLYH · Traditional | Medmetric Corp. | 03/02/1995SE |
| 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 |
More from Far Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K943197 | KT1000/S Knee Ligament ArthrometerLYH · Traditional | 03/02/1995SE |
| 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 |
| K812713 | Drawer TestFTY · Traditional | 11/05/1981SE |
| K801572 | Surg-AssistFWZ · Traditional | 08/04/1980SE |
Questions and answers
When was KT-1000 Device cleared by the FDA?
KT-1000 Device (K812806) received a 510(k) decision of Substantially Equivalent on November 10, 1981, 35 days after the submission was received.
What is the product code of K812806?
The FDA product code is LYH – Arthrometer, a Class I (low risk) device regulated under 21 CFR 890.1615.