Mid Labs Twin Illuminator
FDA 510(k) K932131 · Medical Instrument Development Laboratories, Inc.
510(k) numberK932131
Submission
- Device name
- Mid Labs Twin Illuminator
- Applicant
- Medical Instrument Development Laboratories, Inc.
San Leandro, CA, US - Received
- May 3, 1993
- Decision date
- April 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- EQH – Source, Carrier, Fiberoptic Light
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4350
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EQH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K930123 | Aspirating Endo Ocular ProbeEQH · Traditional | Surgical Technologies, Inc. | 02/16/1994SE |
| K933145 | Fiberoptic Lightsources and CarriersEQH · Traditional | Electro Fiberoptics Corp. | 09/07/1993SE |
| K923227 | Throat-A-ScopeEQH · Traditional | Truphatek, Ltd. | 12/04/1992SE |
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|---|---|---|
| K153168 | Bi-Blade Vitrectomy CutterHQE · Special | 04/29/2016SE |
| K102222 | Ultimate Vit Enhamcer (Uve)HQE · Traditional | 04/08/2011SE |
| K020911 | Mid Labs Autonomous Vit Enhancer (Ave)HQE · Traditional | 04/29/2002SE |
| K992943 | Vit EnhancerHQE · Traditional | 12/10/1999SE |
| K971067 | Digi-InjectorMRH · Traditional | 09/19/1997SE |
| K950287 | Univit ProbeHKP · Traditional | 04/10/1995SE |
| K934600 | MicrodriveHQE · Traditional | 07/27/1994SE |
| K932669 | Supra-Vit(Tm)HQE · Traditional | 06/03/1994SE |
| K924222 | Mid Labs, Inc. Vit MateHQE · Traditional | 01/27/1993SE |
| K851610 | Combined MVS SystemsHQE · Traditional | 07/22/1985SE |
Questions and answers
When was Mid Labs Twin Illuminator cleared by the FDA?
Mid Labs Twin Illuminator (K932131) received a 510(k) decision of Substantially Equivalent on April 1, 1994, 333 days after the submission was received.
What is the product code of K932131?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.