Data / Medical devices / United States / Beacon Biosignals - Cleveland Site
Beacon Biosignals - Cleveland Site: FDA-registered device maker in Cleveland, OH, United States, 1 510(k) clearance
Beacon Biosignals - Cleveland Site is registered with the FDA (registration 1530224) in Cleveland, OH, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2004. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1530224
- FEI number
- 3000206198
- Address
- 4415 Euclid Ave Ste 400, Cleveland, OH, United States, 44103
- Owner or operator
- Beacon Biosignals, Inc. (10088399)
- Roles
- Specification developer
- First device listed
- October 24, 2026
- Registered through
- 2027
- Brand names listed
- IDCheck, Sapphire PSG; Sleep Scout; SleepView, SleepView Web Portal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Specification developer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 17, 2004 | K042039 | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 | OLV | Substantially Equivalent | Cleveland Medical Devices, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Medical Device Data System
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Full-Montage Standard Electroencephalograph
Updated November 17, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.