SCANNING DIRECTOR
Device Facts
| Record ID | K944585 |
|---|---|
| Device Name | SCANNING DIRECTOR |
| Applicant | Prentke Romich Co. |
| Product Code | IQA · Physical Medicine |
| Decision Date | Feb 21, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3725 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered environmental control system is an AC- or battery-powered device intended for medical purposes that is used by a patient to operate an environmental control function. Examples of environmental control functions include the following: to control room temperature, to answer a doorbell or telephone, or to sound an alarm for assistance.
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 § 890.9.
