Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042481106

FEI Number

3042481106

Entity Name

SMART HEALTH LLC

City/State/Country

Owings Mills, MD, US

Establishment Address

10451 Mill Run Cir, Owings Mills, MD 21117, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Smart Health LLC (Owner Number: 10094642)

Owner / Operator Contact Address

10451 Mill Run circle, Owings Mills, MD 21117, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Olympus 1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2025-12-12

Official Correspondent

Bosmat Friedman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smart Health LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042481106. Last updated year: 2026. Please use registration number 3042481106 when referencing this establishment in official correspondence.