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FDA 510(k), K180046, Masimo Rad-97 and Accessories
FDA 510(k), K180046, Masimo Rad-97 and Accessories
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510(K) Number: K180046
Device Name: Masimo Rad-97 and Accessories
Manufacturer: Masimo Corporation
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 01/08/2018
Decision Date: 10/23/2018
Regulation Medical Specialty: Cardiovascular
Device Name: Masimo Rad-97 and Accessories
Manufacturer: Masimo Corporation
Device Classification Name: oximeter
Regulation Number: 870.2700
Classification Product Code: DQA
Date Received: 01/08/2018
Decision Date: 10/23/2018
Regulation Medical Specialty: Cardiovascular
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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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