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Data / Medical devices / United States / NFANT LABS Inc

NFANT LABS Inc: FDA-registered device maker in Port Richey, FL, United States, 1 510(k) clearance

NFANT LABS Inc is registered with the FDA (registration 3012164803) in Port Richey, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 9, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3012164803
Address
6016 Sherwin Drive, Port Richey, FL, United States, 34668
Owner or operator
NFANT Labs LLC (10049999)
Roles
Manufacturer
First device listed
October 5, 2015
Registered through
2026
Brand names listed
NFANT Feeding Solution, nfant Thrive Feeding System

Devices it lists

DeviceProduct codeClassRoleSource
Device, BiofeedbackHCC2Manufactureraccessdata.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
September 9, 2015K143507NFANT Feeding SolutionHCCSubstantially EquivalentNfant Labs, LLCaccessdata.fda.gov

Compare with other makers

Updated September 9, 2015. 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.