F.T.I. Medical Light Guide
FDA 510(k) K904378 · Fiberoptics Technology, Inc.
510(k) numberK904378
Submission
- Device name
- F.T.I. Medical Light Guide
- Applicant
- Fiberoptics Technology, Inc.
Pomfret, CT, US - Received
- September 24, 1990
- Decision date
- January 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4350
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
| K945876 | Weco Endoscopic System with Fiber Optic LightEQH · Traditional | Wells Johnson Co. | 12/04/1995SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | Jedmed Instrument Co. | 11/13/1995SE |
| K951829 | Cold Light Source Los 150EQH · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 07/10/1995SE |
| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | Xomed-Treace, Inc. | 08/24/1994SE |
| K941661 | GM Opti*Cam Camer with Dental Fiber Optic LightEQH · Traditional | Gm Engineering, Inc. | 08/23/1994SE |
| K941662 | GM Opti*Cam Camera with ENT Fiber Optic LightEQH · Traditional | Gm Engineering, Inc. | 07/20/1994SE |
| K934911 | Saphire Plus Surgical MirrorEQH · Traditional | San Diego Swiss Machining, Inc. | 06/21/1994SE |
| K932131 | Mid Labs Twin IlluminatorEQH · Traditional | Medical Instrument Development Laboratories, Inc. | 04/01/1994SE |
| K930123 | Aspirating Endo Ocular ProbeEQH · Traditional | Surgical Technologies, Inc. | 02/16/1994SE |
| K933145 | Fiberoptic Lightsources and CarriersEQH · Traditional | Electro Fiberoptics Corp. | 09/07/1993SE |
More from Electro Fiberoptics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K102167 | LO-50 LED Light SourceNTN · Traditional | 08/17/2010SE |
Questions and answers
When was F.T.I. Medical Light Guide cleared by the FDA?
F.T.I. Medical Light Guide (K904378) received a 510(k) decision of Substantially Equivalent on January 16, 1991, 114 days after the submission was received.
What is the product code of K904378?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.