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FDA 510(k), K162670, RSM 1824C with RConsole1
FDA 510(k), K162670, RSM 1824C with RConsole1
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$149.00 USD
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510(K) Number: K162670
Device Name: RSM 1824C with RConsole1
Manufacturer: DRTECH CORPORATION
Device Classification Name: full field digital, system, x-ray, mammographic
Regulation Number: 892.1715
Classification Product Code: MUE
Date Received: 09/26/2016
Decision Date: 02/23/2017
Regulation Medical Specialty: Radiology
Device Name: RSM 1824C with RConsole1
Manufacturer: DRTECH CORPORATION
Device Classification Name: full field digital, system, x-ray, mammographic
Regulation Number: 892.1715
Classification Product Code: MUE
Date Received: 09/26/2016
Decision Date: 02/23/2017
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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