Concept Video Imaging System
FDA 510(k) K850749 · Concept, Inc.
510(k) numberK850749
Submission
- Device name
- Concept Video Imaging System
- Applicant
- Concept, Inc.
Clearwater, FL, US - Received
- February 25, 1985
- Decision date
- May 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KQM – Camera, Surgical And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4160
- Specialty
- General, Plastic Surgery
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| K885042 | Sony Trinitron Color Video Monitor PVM-1343MDKQM · Traditional | Sony Medical Electronics Co. | 12/22/1988SE |
| K882958 | Sony Video Printers, Up SeriesKQM · Traditional | Sony Medical Electronics Co. | 08/04/1988SE |
| K882924 | Medicam MC-7 and RP-7 Surgical CamerasKQM · Traditional | M.P. Video, Inc. | 07/26/1988SE |
| K873419 | Video Printer SystemKQM · Traditional | Technology For Imaging, Inc. | 11/02/1987SE |
| K871595 | Surgical Camera AccessoriesKQM · Traditional | M.P. Video, Inc. | 05/07/1987SE |
| K863800 | Endoscopic Video CameraKQM · Traditional | Technology For Imaging, Inc. | 10/14/1986SE |
| K860904 | Video Printer, Model 3200KQM · Traditional | Medline Industries, Inc. | 03/28/1986SE |
| K843806 | VIS-1000 Video SystemKQM · Traditional | Vistek Corp. | 12/12/1984SE |
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| K912640 | Concept Endosteal Fixation DeviceHWC · Traditional | 05/01/1992SE |
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| K896648 | Concept Unicompartmental Knee SystemHSX · Traditional | 06/05/1990SN |
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| K892376 | Intravision(Tm) Arthroscope System (Add'L Appli.)HRX · Traditional | 08/01/1989SE |
| K891109 | Panda(R) Needle Catheter Jejunostomy TubeKNT · Traditional | 05/08/1989SE |
| K881954 | Concept Power SystemHSZ · Traditional | 11/09/1988SE |
| K884255 | Concept CCT-5200, Thermal Therapy SystemILO · Traditional | 11/08/1988SE |
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Questions and answers
When was Concept Video Imaging System cleared by the FDA?
Concept Video Imaging System (K850749) received a 510(k) decision of Substantially Equivalent on May 20, 1985, 84 days after the submission was received.
What is the product code of K850749?
The FDA product code is KQM – Camera, Surgical And Accessories, a Class I (low risk) device regulated under 21 CFR 878.4160.