Alpha MC-9S Mobil C-Arm Image Intensifier Unit
FDA 510(k) K883372 · Ausonics Pty , Ltd.
510(k) numberK883372
Submission
- Device name
- Alpha MC-9S Mobil C-Arm Image Intensifier Unit
- Applicant
- Ausonics Pty , Ltd.
Suffield, CT, US - Received
- August 10, 1988
- Decision date
- November 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Alpha MC-9S Mobil C-Arm Image Intensifier Unit cleared by the FDA?
Alpha MC-9S Mobil C-Arm Image Intensifier Unit (K883372) received a 510(k) decision of Substantially Equivalent on November 25, 1988, 107 days after the submission was received.
What is the product code of K883372?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.