Device Listing 1859226339

Listing Summary

Listing key
1859226339
Premarket submission
K181524
Device
Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART
Applicant
Vyaire Medical, Inc.
Product code
BZC
Decision date
2018-11-30

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
16141313144171314417SunMed Group Holdings, LLC1Y2026-01-012710 Northridge Dr NW Ste A Grand Rapids MI US 49544
31773980306733004213967Rob Yamashita1N2026-01-012710 Northridge Drive NW - Suite A Grand Rapids MI US 49544