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
1842897094
Device Listing 1842897094
Listing Summary
#
Listing key
1842897094
Premarket submission
K243650
Device
Zio® monitor (DFG0001)
Applicant
iRhythm Technologies, Inc.
Product code
DSH
Decision date
2025-08-15
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
89972
3007208829
3007208829
IRHYTHM TECHNOLOGIES, INC.
1
N
2026-01-01
699 8th Street Suite 600 San Francisco CA US 94103
303067
3021769057
3021769057
iRhythm Technologies, Inc.
1
N
2026-01-01
6550 Katella Avenue Cypress CA US 90630