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
1715242768
Device Listing 1715242768
Listing Summary
#
Listing key
1715242768
Premarket submission
K053140
Device
AMBU MARK IV RESUSCITATOR
Applicant
Ambu A/S
Product code
BTM
Decision date
2005-12-23
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
80359
9610691
3002806359
Ambu A/S
1
N
2026-01-01
Baltorpbakken 13 Ballerup Hovedstaden DK DK-2750
8952
3003924186
3003924186
Sanjay Parikh
1
N
2026-01-01
6721 Columbia Gateway Drive, Suite 200 Columbia MD US 21046