Patient Positioning Accessories
FDA 510(k) K895500 · Perkins Mfg. Co.
510(k) numberK895500
Submission
- Device name
- Patient Positioning Accessories
- Applicant
- Perkins Mfg. Co.
Dallas, TX, US - Received
- September 12, 1989
- Decision date
- November 6, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Patient Positioning Accessories cleared by the FDA?
Patient Positioning Accessories (K895500) received a 510(k) decision of Substantially Equivalent on November 6, 1989, 55 days after the submission was received.
What is the product code of K895500?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.