KZF · Device, Medical Examination, Ac Powered
General Hospital · 21 CFR 880.6320 · Class 1
Overview
| Product Code | KZF |
|---|---|
| Device Name | Device, Medical Examination, Ac Powered |
| 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 (20 of 37)
Showing 20 most recent of 37 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954943 | NEVOSCOPE | Nizar A. Mullani | Mar 27, 1996 | SESE |
| K952835 | WELCH ALLYN VIDEO EPISCOPE | Welch Allyn, Inc. | Sep 22, 1995 | SESE |
| K945507 | H 5100, H 5200, H 5300 | Rudolf Riester GmbH & Co. KG | Dec 9, 1994 | SESE |
| K941869 | SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG | The Lighthouse For the Blind, Inc. | Aug 3, 1994 | SESE |
| K936088 | WAVE FLUORESCENT MAGNIFIER | Burton Medical Products Corp. | Apr 26, 1994 | SESE |
| K940284 | MEDDEV MULTARRAY MEDICAL EXAMINING LIGHT MODIFICATION | Meddev International Corp. | Feb 28, 1994 | SESE |
| K933564 | SKYTRON EXAM LIGHT | Skytron, Div. the Kmw Group, Inc. | Feb 10, 1994 | SESE |
| K935832 | CHROMOPHARE | Berchtold Holding GmbH | Feb 3, 1994 | SESE |
| K934259 | AC-POWERED MEDICAL EXAMINATION LIGHT | Welch Allyn, Inc. | Jan 28, 1994 | SESE |
| K932719 | RITTER MODEL 158 AND 159 EXAM LIGHTS | Midmark Corp. | Dec 2, 1993 | SESE |
| K924447 | VITAPEN | Vitajet Corp. | Sep 27, 1993 | SESE |
| K931197 | MEDDEV MULTARRAY (TM) MEDICAL EXAMINATION LIGHT | Meddev International Corp. | Sep 23, 1993 | SESE |
| K931645 | HALUX TASKLIGHT | Burton Medical Products Corp. | Aug 20, 1993 | SESE |
| K931646 | MI-4 VARIABLE SPOT LIGHT | Medical Illumination, Inc. | Aug 19, 1993 | SESE |
| K931026 | MI-5 DIAGNOSTIC LIGHT | Medical Illumination, Inc. | Aug 19, 1993 | SESE |
| K925710 | M.E.D. LIGHT | Medical Illumination, Inc. | Jun 4, 1993 | SESE |
| K922282 | ILLUMINATOR VIII ULTRA/SPOT | Medical Illumination, Inc. | Mar 4, 1993 | SESE |
| K922278 | ILLUMINATOR III | Medical Illumination, Inc. | Mar 4, 1993 | SESE |
| K922281 | ILLUMINATOR VII MINI/SPOT LIGHT | Medical Illumination, Inc. | Feb 5, 1993 | SESE |
| K922280 | ILLUMINATOR VII MINI/LUM LIGHT | Medical Illumination, Inc. | Feb 5, 1993 | SESE |
Top Applicants
- Medical Illumination, Inc. — 8 clearances
- Burton Medical Products Corp. — 7 clearances
- Welch Allyn, Inc. — 6 clearances
- Meddev International Corp. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
