Glooko Inc

FDA Device Registration & Listing · Palo Alto, CA, US · Registration 3009137498

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
3009137498
FEI Number
3009137498
Entity Name
Glooko Inc
City/State/Country
Palo Alto, CA, US
Establishment Address
579 University Ave, Palo Alto, CA 94301, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Glooko, Inc (Owner Number: 10038854)
Owner / Operator Contact Address
579 University Avenue, Palo Alto, CA 94301, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Glooko Transmitter Glooko System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUG Medical Device Data System General Hospital Class 1 880.6310 2011-11-17
PHV Continuous Glucose Monitor Retrospective Data Analysis Software Clinical Chemistry Class 1 862.2120 2016-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009864844 Monarch Medical Technologies Charlotte, NC, US

Similar Registrations

Registration Number Establishment Name Location
3026606276 KEY ASIC BERHAD PETALING JAYA Selangor, MY
3043603319 MEDICARE TAGS LIMITED T/A MEDYTRAK Galway, IE
3002725312 AMERICAN PORTWELL TECHNOLOGY, INC. Fremont, CA, US
3007832484 JWP MANUFACTURING Santa Clara, CA, US
3037966017 HEALTH DATA WORKS Ponte Vedra Beach, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009137498. Last updated year: 2026. Please use registration number 3009137498 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.