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
1200810190
Device Listing 1200810190
Listing Summary
#
Listing key
1200810190
Premarket submission
K230991
Device
PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E
Applicant
Given Imaging Ltd. (Medtronic)
Product code
NEZ
Decision date
2023-06-30
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
332181
9710107
3003348376
GIVEN IMAGING LTD.
1
N
2026-01-01
2 Hacarmel St. NEW INDUSTRIAL Park, POB 258 Yoqneam Northern IL 2069204