FDA.reportPublic FDA data

Outset Medical, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103558463010355846Outset Medical, Inc.1N2026-01-013052 Orchard Drive San Jose CA US 95134

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850001011266Tablo(R) Hemodialysis System - Tablo Console(669) 231-8200CS@outsetmedical.com
00850001011341Tablo(R) Hemodialysis System - Tablo Console(669) 231-8200CS@outsetmedical.com
00850001011358Tablo(R) Hemodialysis System - Tablo Console(669) 231-8200CS@outsetmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1744771115839561K233335Tablo® Hemodialysis SystemKDI2023-12-05
1744771202292973K232776Tablo® Hemodialysis System; TabloCart™ with Prefiltration DrawerKDI2024-05-03
1744771619670028K223248Tablo® Hemodialysis SystemKDI2023-06-21
1744771314545143K211370Tablo Hemodialysis SystemKDI2022-07-29
1744771293092549K210782Tablo CartridgeFJK2021-11-26
1744771414581063K200741Tablo Hemodialysis SystemKDI2020-03-31
1744771637956625K190793Tablo Hemodialysis System, Tablo CartridgeKDI2019-12-12
1744771776920715K160881Tablo ConsoleKDI2016-11-15
1744771965043967K140841TABLO CARTRIDGEFJK2014-09-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI72024-05-03
FJK22021-11-26

PMN#

GUDID#