Bennett BCA-6 &BCA-9 Mobile C-Arm Unit/Radio/Flour
FDA 510(k) K883092 · Bennett X-Ray Corp.
510(k) numberK883092
Submission
- Device name
- Bennett BCA-6 &BCA-9 Mobile C-Arm Unit/Radio/Flour
- Applicant
- Bennett X-Ray Corp.
Copiague, NY, US - Received
- July 22, 1988
- Decision date
- October 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K940701 | Bennett Mammography Positioning Chair Model No. M-PchIZH · Traditional | 04/28/1994SE |
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Questions and answers
When was Bennett BCA-6 &BCA-9 Mobile C-Arm Unit/Radio/Flour cleared by the FDA?
Bennett BCA-6 &BCA-9 Mobile C-Arm Unit/Radio/Flour (K883092) received a 510(k) decision of Substantially Equivalent on October 13, 1988, 83 days after the submission was received.
What is the product code of K883092?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.