PEQ · Accessories To Examination Light
General Hospital · 21 CFR 880.6320 · Class 1
Overview
| Product Code | PEQ |
|---|---|
| Device Name | Accessories To Examination Light |
| Regulation | 21 CFR 880.6320 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
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 § 880.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131338 | DERMA HOOD | Globalmedia Group, LLC | Jul 10, 2013 | SESE |
Top Applicants
- Globalmedia Group, LLC — 1 clearance
