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
1032793766
Device Listing 1032793766
Listing Summary
#
Listing key
1032793766
Premarket submission
K181497
Device
HPM-6000UF
Applicant
BTL Industries, Inc.
Product code
KPI
Decision date
2018-11-14
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
23919
3005028741
3005028741
David Chmel
1
N
2020-04-25
362 Elm Street Marlborough MA US 01752
335200
3035374386
3035374386
BTL Industries JSC
1
N
2026-01-01
Vladaya 3 Plovdiv BG 4006