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
1722187029
Device Listing 1722187029
Listing Summary
#
Listing key
1722187029
Premarket submission
K213334
Device
Monarch Platform, Urology
Applicant
Auris Health, Inc.
Product code
FGB
Decision date
2022-04-29
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
300226
3017425975
3014447948
Auris Health, Inc
1
N
2026-01-01
5490 Great America Pkwy Santa Clara CA US 95054
307997
3023460764
3023460764
Auris Health, Inc.
1
N
2026-01-01
170 Baytech Drive San Jose CA US 95134