Device Listing 1124829450

Listing Summary#

Listing key
1124829450
Premarket submission
K153193
Device
Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)
Applicant
Zyno Medical, LLC
Product code
FRN
Decision date
2016-08-30