Mediseal Camera Covers
FDA 510(k) K810512 · Janin Group, Inc.
510(k) numberK810512
Submission
- Device name
- Mediseal Camera Covers
- Applicant
- Janin Group, Inc.
Mchenry, IL, US - Received
- February 24, 1981
- Decision date
- March 13, 1981
- 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
Other 510(k)s with product code KQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900160 | Adaptor: Kaps Cine to Moeller BeamsplitterKQM · Traditional | Jedmed Instrument Co. | 01/24/1990SE |
| K890826 | Sony Video Graphic Printer UP-850KQM · Traditional | Sony Corp. of America | 03/14/1989SE |
| 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 |
| K850749 | Concept Video Imaging SystemKQM · Traditional | Concept, Inc. | 05/20/1985SE |
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Questions and answers
When was Mediseal Camera Covers cleared by the FDA?
Mediseal Camera Covers (K810512) received a 510(k) decision of Substantially Equivalent on March 13, 1981, 17 days after the submission was received.
What is the product code of K810512?
The FDA product code is KQM – Camera, Surgical And Accessories, a Class I (low risk) device regulated under 21 CFR 878.4160.