Jedmed CCD Camera System
FDA 510(k) K862664 · Jedmed Instrument Co.
510(k) numberK862664
Submission
- Device name
- Jedmed CCD Camera System
- Applicant
- Jedmed Instrument Co.
St. Louis, MO, US - Received
- July 14, 1986
- Decision date
- July 30, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FWD – Camera, Television, Microsurgical, Without Audio
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FWD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K891236 | FDX Solid State Video Camera Model 5950FWD · Traditional | Medical Dynamics, Inc. | 04/05/1989SE |
| K882166 | Jedmed Micro CCD Camera SystemFWD · Traditional | Jedmed Instrument Co. | 06/15/1988SE |
| K862145 | Jedmed Mini-Mos Video CameraFWD · Traditional | Jedmed Instrument Co. | 06/13/1986SE |
| K862034 | Jedmed CCD-02 Video Camera SystemFWD · Traditional | Jedmed Instrument Co. | 06/09/1986SE |
More from Jedmed Instrument Co.
| 510(k) | Device | Decision |
|---|---|---|
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | 07/23/2015SE |
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | 02/21/2014SE |
| K021750 | Lid Chain Eyelid WeightsMML · Traditional | 01/27/2003SE |
| K954184 | Jed-Light Fiberoptic Light SourceEQH · Traditional | 11/13/1995SE |
| K944032 | Video Scope System (Laryngoscope)ENZ · Traditional | 09/15/1995SE |
| K953457 | Jedmed Spectrum ENT CabinetETF · Traditional | 08/11/1995SE |
| K950925 | Jedmed Laryngeal ScopeEOQ · Traditional | 08/11/1995SE |
| K950785 | Hortmann Airmatic Air Caloric StimulatorKHH · Traditional | 06/28/1995SE |
| K950078 | Microflow Irrigation SystemKMA · Traditional | 06/21/1995SE |
| K944671 | Video Scope System (Nasopharyngoscope {Flexible or Rigid})EOB · Traditional | 02/07/1995SE |
Questions and answers
When was Jedmed CCD Camera System cleared by the FDA?
Jedmed CCD Camera System (K862664) received a 510(k) decision of Substantially Equivalent on July 30, 1986, 16 days after the submission was received.
What is the product code of K862664?
The FDA product code is FWD – Camera, Television, Microsurgical, Without Audio, a Class I (low risk) device regulated under 21 CFR 878.4160.