Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1286569302
Device Listing 1286569302
Listing Summary
#
Listing key
1286569302
Premarket submission
K260455
Device
New Wave System
Applicant
Zeto, Inc.
Product code
GWQ
Decision date
2026-03-13
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
287582
3017970307
3017970307
Zeto EU Kft.
1
N
2026-01-01
Zoltan Utca 6 Szeged HU 6724
302523
3021826057
3021826057
ZETO, INC.
1
Y
2026-01-01
5565 Centerview Dr Ste 105 Raleigh NC US 27606