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Fiab SPA: FDA-registered device maker in Vicchio Firenze, Italy, 7 510(k) clearances

Name: Fiab SPA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fiab SPA is registered with the FDA (registration 3003072803) in Vicchio Firenze, Italy. It lists 7 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 10, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003072803
Address: Via Costoli, 4, Vicchio Firenze, Italy, 50039
Owner or operator: Fiab SpA (10027015)
Roles: Exporter to the US, Manufacturer
First device listed: July 29, 2009
Registered through: 2026
Brand names listed: 2615358H/US Esotest Multi Probe 5 sensors, 2617376H/US Esotest Multi Probe 7 sensors, 30115 Esotest Multi Monitor, DISPOSABLE FULLY GELLEDE NEUROSTIMULATION ELECTRODES WITH CABLE, DISPOSABLE FULLY GELLEDE NEUROSTIMULATION ELECTRODES WITH SNAP, F5417/US Esotest Multi Patient Cable, F7817TPM70/30/US Esotest Multi Adapter Cable, FIAB ECG ACCESSORIES and more

Devices it lists

Device	Product code	Class	Role	Source
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Manufacturer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Unit, Cautery, Thermal, Battery-Powered	HQP	2	Manufacturer	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
October 10, 2019	K192210	ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System	FLL	Substantially Equivalent	Fiab Spa	accessdata.fda.gov
November 8, 2018	K180047	ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System	FLL	Substantially Equivalent	Fiab Spa	accessdata.fda.gov
February 27, 2013	K123361	ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM	FLL	Substantially Equivalent	Fiab Spa	accessdata.fda.gov
June 16, 2011	K103783	EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC	LDD	Substantially Equivalent	Fiab Spa	accessdata.fda.gov
June 21, 2010	K100333	FIAB SPA, MODELS F7244, F7233, F7234, F7277	GEI	Substantially Equivalent	Fiab Spa	accessdata.fda.gov
September 1, 2009	K083428	F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY	HQP	Substantially Equivalent	Fiab Spa	accessdata.fda.gov
July 22, 2009	K091163	PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST	GXY	Substantially Equivalent	Fiab Spa	accessdata.fda.gov

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Updated October 10, 2019. 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.