SLS Simulator (Models SLS-9 and SLS-14)
FDA 510(k) K891293 · Philips Medical Systems North America, Inc.
510(k) numberK891293
Submission
- Device name
- SLS Simulator (Models SLS-9 and SLS-14)
- Applicant
- Philips Medical Systems North America, Inc.
Shelton, CT, US - Received
- March 10, 1989
- Decision date
- April 20, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was SLS Simulator (Models SLS-9 and SLS-14) cleared by the FDA?
SLS Simulator (Models SLS-9 and SLS-14) (K891293) received a 510(k) decision of Substantially Equivalent on April 20, 1989, 41 days after the submission was received.
What is the product code of K891293?
The FDA product code is KPQ – System, Simulation, Radiation Therapy, a Class II (moderate risk) device regulated under 21 CFR 892.5840.