EpiWatch, Inc.

FDA Device Registration & Listing · Baltimore, MD, US · Registration 3043349255

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
3043349255
FEI Number
3043349255
Entity Name
EpiWatch, Inc.
City/State/Country
Baltimore, MD, US
Establishment Address
1812 Ashland Ave Ste 110, Baltimore, MD 21205, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
EpiWatch, Inc. (Owner Number: 10095197)
Owner / Operator Contact Address
1812 Ashland Avenue, Suite 110, Baltimore, MD 21205, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243515
PMA Number
N/A

All Registered Proprietary Names

EpiWatch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
POS Physiological Signal Based Seizure Monitoring System Neurology Class 2 882.1580 2026-02-04

Official Correspondent

Teresa Prego

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EpiWatch, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043349255. Last updated year: 2026. Please use registration number 3043349255 when referencing this establishment in official correspondence.
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