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
1115839561
Device Listing 1115839561
Listing Summary
#
Listing key
1115839561
Premarket submission
K233335
Device
Tablo® Hemodialysis System
Applicant
Outset Medical, Inc.
Product code
KDI
Decision date
2023-12-05
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
174477
3010355846
3010355846
Outset Medical, Inc.
1
N
2026-01-01
3052 Orchard Drive San Jose CA US 95134
281958
3017552925
3017552925
Baja Fur S.A. de C.V.
1
N
2026-01-01
C. Vecinal #20601 Modulos J y K Col. Presa Rodriguez Tijuana Baja California MX C.P. 22124
338050
3038138522
3038138522
Baja Fur S.A. de C.V.
1
N
2026-01-01
Blv. Agua Caliente 8582-5 Zona Centro Tijuana BC. Baja California MX 22000