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FDA 510(k), K090020, BEL-CYPHER, MODEL Y977
FDA 510(k), K090020, BEL-CYPHER, MODEL Y977
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510(K) Number: K090020
Device Name: BEL-CYPHER, MODEL Y977
Manufacturer: KUNIHIKO SOBUE
Device Classification Name: System, X-Ray, Extraoral Source, Digital
Regulation Number: MUH
Classification Product Code: 01/05/2009
Date Received: 03/13/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: BEL-CYPHER, MODEL Y977
Manufacturer: KUNIHIKO SOBUE
Device Classification Name: System, X-Ray, Extraoral Source, Digital
Regulation Number: MUH
Classification Product Code: 01/05/2009
Date Received: 03/13/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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