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FDA 510(k), K171565, OEC Elite
FDA 510(k), K171565, OEC Elite
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510(K) Number: K171565
Device Name: OEC Elite
Manufacturer: GE OEC Medical Systems, Inc.
Device Classification Name: Interventional Fluoroscopic X-Ray System
Regulation Number: 892.1650
Classification Product Code: OWB
Date Received: 05/30/2017
Decision Date: 08/10/2017
Regulation Medical Specialty: Radiology
Device Name: OEC Elite
Manufacturer: GE OEC Medical Systems, Inc.
Device Classification Name: Interventional Fluoroscopic X-Ray System
Regulation Number: 892.1650
Classification Product Code: OWB
Date Received: 05/30/2017
Decision Date: 08/10/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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