Mobile X-Ray Television Unit WHA-10A/B
FDA 510(k) K895394 · Shimadzu Corp.
510(k) numberK895394
Submission
- Device name
- Mobile X-Ray Television Unit WHA-10A/B
- Applicant
- Shimadzu Corp.
Kyoto City 604 Japan, JP - Received
- September 6, 1989
- Decision date
- November 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Mobile X-Ray Television Unit WHA-10A/B cleared by the FDA?
Mobile X-Ray Television Unit WHA-10A/B (K895394) received a 510(k) decision of Substantially Equivalent on November 13, 1989, 68 days after the submission was received.
What is the product code of K895394?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.