Sony Cine Video System SME-3500
FDA 510(k) K904447 · Sony Medical Electronics Co.
510(k) numberK904447
Submission
- Device name
- Sony Cine Video System SME-3500
- Applicant
- Sony Medical Electronics Co.
Park Ridge, NJ, US - Received
- September 28, 1990
- Decision date
- October 17, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K885042 | Sony Trinitron Color Video Monitor PVM-1343MDKQM · Traditional | 12/22/1988SE |
| K884008 | Sony Cine Video System SME-3300IZI · Traditional | 11/30/1988SE |
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Questions and answers
When was Sony Cine Video System SME-3500 cleared by the FDA?
Sony Cine Video System SME-3500 (K904447) received a 510(k) decision of Substantially Equivalent on October 17, 1990, 19 days after the submission was received.
What is the product code of K904447?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.