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FDA 510(k), K092837, OTI-SCAN 3000
FDA 510(k), K092837, OTI-SCAN 3000
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510(K) Number: K092837
Device Name: OTI-SCAN 3000
Manufacturer: OPKO INSTRUMENTATION, INC
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 09/15/2009
Decision Date: 12/23/2009
Regulation Medical Specialty: Radiology
Device Name: OTI-SCAN 3000
Manufacturer: OPKO INSTRUMENTATION, INC
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 09/15/2009
Decision Date: 12/23/2009
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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