Fiber Optic Adapter #60-0896
FDA 510(k) K802775 · Aspen Laboratories, Inc.
510(k) numberK802775
Submission
- Device name
- Fiber Optic Adapter #60-0896
- Applicant
- Aspen Laboratories, Inc.
- Received
- November 3, 1980
- Decision date
- December 16, 1980
- 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
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 |
| 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 |
|---|---|---|
| K981220 | System 7500 Abc Electrosurgical UnitGEI · Traditional | 04/21/1998SE |
| K963088 | Sheath, Electrosurgical PencilGEI · Traditional | 09/13/1996SE |
| K955834 | System 6500 Abc Electrosurgical UnitGEI · Traditional | 07/11/1996SE |
| K960296 | 4000 EtmGEI · Traditional | 02/20/1996SE |
| K953081 | Beamer PlusGEI · Traditional | 10/30/1995SE |
| K953007 | Excalibur Plus Electrosurgical UnitGEI · Traditional | 08/21/1995SE |
| K946104 | Smokievac Electrosurgical PencilGEI · Traditional | 04/03/1995SE |
| K944012 | Electrosurgical Flexible Electrode In-Line Suction CoagulatorGEI · Traditional | 12/21/1994SE |
| K924960 | Excalibur Electrosurgical UnitGEI · Traditional | 04/16/1993SE |
| K913213 | Single Use Lee ElectrodeHGI · Traditional | 02/13/1992SE |
Questions and answers
When was Fiber Optic Adapter #60-0896 cleared by the FDA?
Fiber Optic Adapter #60-0896 (K802775) received a 510(k) decision of Substantially Equivalent on December 16, 1980, 43 days after the submission was received.
What is the product code of K802775?
The FDA product code is EQH – Source, Carrier, Fiberoptic Light, a Class I (low risk) device regulated under 21 CFR 874.4350.