Sony PGM-100P1MD Trinitron Color Graphic Monitor
FDA 510(k) K970999 · Sony Medical Systems
510(k) numberK970999
Submission
- Device name
- Sony PGM-100P1MD Trinitron Color Graphic Monitor
- Applicant
- Sony Medical Systems
North Attleboro, MA, US - Received
- March 19, 1997
- Decision date
- May 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Sony PGM-100P1MD Trinitron Color Graphic Monitor cleared by the FDA?
Sony PGM-100P1MD Trinitron Color Graphic Monitor (K970999) received a 510(k) decision of Substantially Equivalent on May 20, 1997, 62 days after the submission was received.
What is the product code of K970999?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.