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Data / Medical devices / United States / Bleep, LLC

Bleep, LLC: FDA-registered device maker in Chapel Hill, NC, United States, 1 510(k) clearance

Bleep, LLC is registered with the FDA (registration 3015436853) in Chapel Hill, NC, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 30, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015436853
Address
11312 US 15-501 North Suite, Chapel Hill, NC, United States, 27517
Owner or operator
Bleep, LLC (10059770)
Roles
Manufacturer
First device listed
February 21, 2019
Registered through
2026
Brand names listed
DreamPort, DreamPort Sleep Solution, DreamWay, Eclipse, Halos

Devices it lists

DeviceProduct codeClassRoleSource
Ventilator, Non-Continuous (Respirator)BZD2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 30, 2018K172335Bleep DreamPortBZDSubstantially EquivalentSnapcpapaccessdata.fda.gov

Compare with other makers

Updated March 30, 2018. 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.