Bcm-Arc 105 X-Ray Mobile Unit
FDA 510(k) K890306 · B C Medical , Ltd.
510(k) numberK890306
Submission
- Device name
- Bcm-Arc 105 X-Ray Mobile Unit
- Applicant
- B C Medical , Ltd.
J3y 7p9, CA - Received
- January 23, 1989
- Decision date
- April 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Bcm-Arc 105 X-Ray Mobile Unit cleared by the FDA?
Bcm-Arc 105 X-Ray Mobile Unit (K890306) received a 510(k) decision of Substantially Equivalent on April 17, 1989, 84 days after the submission was received.
What is the product code of K890306?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.