FDA.reportPublic FDA data

ETIOMETRY INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30116831003011683100ETIOMETRY INC.1N2026-01-01770 Legacy Place Floor 2, Suite 34 Dedham MA US 02026

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00863061000309T3 Risk Analytics Platform - Etiometry Platform8573669333support@etiometry.com
00863061000316T3 PLATFORM SOFTWARE - Etiometry Platform8573669333support@etiometry.com
00863061000323ETIOMETRY PLATFORM - 28573669333support@etiometry.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1837251771362957K241479Etiometry Platform (DAV 5.4 RAE 9.2)PPW2025-02-12
1837251200774163K223578T3 Platform softwarePPW2023-07-07
1837251471911136K213423T3 Platform softwarePLB2023-01-06
1837251494435523K213230T3 Platform SoftwarePPW2022-06-22
1837251260338271K202306T3 Platform softwareMWI2020-11-25
1837251206761566K190273T3 Platform softwareMWI2019-12-08
1837251929738824K163065T3 SoftwareMWI2017-05-26
1837251791102050

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PPW32025-02-12
MWI32020-11-25
PLB12023-01-06

PMN#

GUDID#