Polarix 2 and Polarix 2E
FDA 510(k) K884578 · Dyna-Med
510(k) numberK884578
Submission
- Device name
- Polarix 2 and Polarix 2E
- Applicant
- Dyna-Med
Victoria, TX, US - Received
- November 1, 1988
- Decision date
- February 9, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Polarix 2 and Polarix 2E cleared by the FDA?
Polarix 2 and Polarix 2E (K884578) received a 510(k) decision of Substantially Equivalent on February 9, 1989, 100 days after the submission was received.
What is the product code of K884578?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.