Sony Cine Video System SME-3300
FDA 510(k) K884008 · Sony Medical Electronics Co.
510(k) numberK884008
Submission
- Device name
- Sony Cine Video System SME-3300
- Applicant
- Sony Medical Electronics Co.
North Attleboro, MA, US - Received
- September 21, 1988
- Decision date
- November 30, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K902535 | Sony WBS-700H Videocassette Recorder SystemJAA · Traditional | 06/29/1990SE |
| K901153 | Sony VO-5800H Videocassette RecorderJAA · Traditional | 04/19/1990SE |
| K885042 | Sony Trinitron Color Video Monitor PVM-1343MDKQM · Traditional | 12/22/1988SE |
| K882958 | Sony Video Printers, Up SeriesKQM · Traditional | 08/04/1988SE |
Questions and answers
When was Sony Cine Video System SME-3300 cleared by the FDA?
Sony Cine Video System SME-3300 (K884008) received a 510(k) decision of Substantially Equivalent on November 30, 1988, 70 days after the submission was received.
What is the product code of K884008?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.