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FDA 510(k), K160016, Steth IO
FDA 510(k), K160016, Steth IO
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510(K) Number: K160016
Device Name: Steth IO
Manufacturer: STRATOSCIENTIFIC, INC.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 01/05/2016
Decision Date: 07/15/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Steth IO
Manufacturer: STRATOSCIENTIFIC, INC.
Device Classification Name: Stethoscope, Electronic
Regulation Number: 870.1875
Classification Product Code: DQD
Date Received: 01/05/2016
Decision Date: 07/15/2016
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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