FDA.reportPublic FDA data

AMBULATORY MONITORING, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
24308632430863AMBULATORY MONITORING, INC.1N2026-01-01731 SAW MILL RIVER RD. ARDSLEY NY US 10502

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
370881862808051K854030WRIST ACTIGRAPHGWQ1986-06-25
370881009723038K772016RESPITRACEBZK1978-01-26
370881053893629K251574Sleep WatchLEL2025-07-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LEL12025-07-31
GWQ11986-06-25
BZK11978-01-26

PMN#

ACTILLUME

1989-12-22

AMBULATORY MONITORING, INC.