GEREONICS, INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 2025694

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
2025694
FEI Number
2025694
Entity Name
GEREONICS, INC.
City/State/Country
Irvine, CA, US
Establishment Address
117 Sanctuary, Irvine, CA 92620, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GEREONICS, INC. (Owner Number: 2025694)
Owner / Operator Contact Address
117 Sanctuary, --, Irvine, CA 92620, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K983449
PMA Number
N/A

All Registered Proprietary Names

BraiNet GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GXY Electrode, Cutaneous Neurology Class 2 882.1320 2026-02-19
GXZ Electrode, Needle Neurology Class 2 882.1350 2026-02-19
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2007-08-20

Official Correspondent

MAZDAK ROOEIN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GEREONICS, INC.
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
K070612 Top-Rank Health Care Equipment Co., Ltd. TOP-RANK ADHESIVE ELECTRODE 2007-05-07
K123915 Grass Technologies, an Astro-Med, Inc. Product Gro DE48-PLUS 2013-04-24
K073532 Technomed Europe DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES 2008-05-01
K260363 Ceribell, Inc. Ceribell Brain Monitor Headband 2026-04-03
K091762 Covidien DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE 2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025694. Last updated year: 2026. Please use registration number 2025694 when referencing this establishment in official correspondence.
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