1
/
of
0
FDA 510(k), K142702, Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
FDA 510(k), K142702, Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K142702
Device Name: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 09/22/2014
Decision Date: 12/18/2014
Regulation Medical Specialty: Cardiovascular
Device Name: Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
Manufacturer: MEDIVANCE, INC.
Device Classification Name: System, Thermal Regulating
Regulation Number: 870.5900
Classification Product Code: DWJ
Date Received: 09/22/2014
Decision Date: 12/18/2014
Regulation Medical Specialty: Cardiovascular
Couldn't load pickup availability
- 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.
View full details