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
1181615785
Device Listing 1181615785
Listing Summary
#
Listing key
1181615785
Premarket submission
K201632
Device
TOMTEC-ARENA
Applicant
Tomtec Imaging Systems GmbH
Product code
LLZ
Decision date
2020-08-14
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
1227
3019216
3019216
Philips Ultrasound LLC
1
Y
2026-01-01
22100 Bothell Everett Hwy BOTHELL WA US 98021
280670
8043836
1000185293
Ondrea Bermudez
1
N
2026-01-01
3721 VALLEY CENTRE DR San Diego CA US 92130
283249
3000126629
3000126629
Philips Electronics Ltd
1
N
2026-01-01
1875 Buckhorn Gate, 5th Floor Mississauga Ontario CA L4W 5P1