LYH · Arthrometer
Physical Medicine · 21 CFR 890.1615 · Class 1
Overview
| Product Code | LYH |
|---|---|
| Device Name | Arthrometer |
| Regulation | 21 CFR 890.1615 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943197 | KT1000/S KNEE LIGAMENT ARTHROMETER | Medmetric Corp. | Mar 2, 1995 | SESE |
| K942059 | KT2000 KNEE LIGAMENT ARTHROMETER | Medmetric Corp. | Sep 20, 1994 | SESE |
| K881876 | DYNAMIC CRUCIATE TESTER | Dyonics, Inc. | Nov 17, 1988 | SESE |
| K834462 | GENUCOM | Far Orthopedics, Inc. | Feb 9, 1984 | SESE |
| K812806 | KT-1000 DEVICE | Medmetric Corp. | Nov 10, 1981 | SESE |
Top Applicants
- Medmetric Corp. — 3 clearances
- Dyonics, Inc. — 1 clearance
- Far Orthopedics, Inc. — 1 clearance
