OPERATIVE RECORDING CAMERA
Device Facts
| Record ID | K904113 |
|---|---|
| Device Name | OPERATIVE RECORDING CAMERA |
| Applicant | Medical Dynamics, Inc. |
| Product Code | IKO · Physical Medicine |
| Decision Date | Oct 30, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.1450 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.
Special Controls
*Classification.* Class II (special 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.
