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FDA 510(k), K093694, GERATHERM UNIQUERESC
FDA 510(k), K093694, GERATHERM UNIQUERESC
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510(K) Number: K093694
Device Name: GERATHERM UNIQUERESC
Manufacturer: ANDREA PECSI
Device Classification Name: System, Thermal Regulating
Regulation Number: DWJ
Classification Product Code: 11/30/2009
Date Received: 09/20/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: GERATHERM UNIQUERESC
Manufacturer: ANDREA PECSI
Device Classification Name: System, Thermal Regulating
Regulation Number: DWJ
Classification Product Code: 11/30/2009
Date Received: 09/20/2010
Decision Date: Substantially Equivalent (SESE)
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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