Wellinks

FDA Device Registration & Listing · New Haven, CT, US · Registration 3011166598

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011166598
FEI Number
3011166598
Entity Name
Wellinks
City/State/Country
New Haven, CT, US
Establishment Address
85 Willow St, New Haven, CT 06511, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Wellinks (Owner Number: 10085671)
Owner / Operator Contact Address
85 Willow Street, New Haven, CT 06511, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K192952
PMA Number
N/A

All Registered Proprietary Names

Spire Health Remote Patient Monitoring System Spire Remote Patient Monitoring System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2022-07-18

Official Correspondent

Amy Aquilino

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wellinks
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973527 Data Critical Corp. CARDIO-PAGER SYSTEM 1998-03-31
K182637 Philips Medizin Systeme Boeblingen GmbH Philips IntelliVue XDS Software 2019-04-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011166598. Last updated year: 2026. Please use registration number 3011166598 when referencing this establishment in official correspondence.
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