Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1530224

FEI Number

3000206198

Entity Name

Beacon Bio Dx, LLC dba CleveMed

City/State/Country

CLEVELAND, OH, US

Establishment Address

4415 Euclid Avenue, Ste # 400, CLEVELAND, OH 44103, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Beacon Bio Dx,LLC dba CleveMed (Owner Number: 9023591)

Owner / Operator Contact Address

4415 EUCLID AVE., --, Cleveland, OH 44103, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sapphire PSG SleepView Sleep Scout SleepView Web Portal IDcheck

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2007-12-27
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-12-27
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2011-05-16
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2013-10-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Beacon Bio Dx,LLC dba CleveMed

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
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1530224. Last updated year: 2026. Please use registration number 1530224 when referencing this establishment in official correspondence.