Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003072803

FEI Number

3003072803

Entity Name

FIAB SPA

City/State/Country

Vicchio Firenze, IT

Establishment Address

Via Costoli, 4, Vicchio Firenze 50039, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fiab SpA (Owner Number: 10027015)

Owner / Operator Contact Address

Via Costoli 4, Vicchio, IT-FI 50039, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100333

PMA Number

N/A

All Registered Proprietary Names

30115 Esotest Multi Monitor 2615358H/US Esotest Multi Probe 5 sensors F5417/US Esotest Multi Patient Cable 2617376H/US Esotest Multi Probe 7 sensors F7817TPM70/30/US Esotest Multi Adapter Cable Sensitherm Multi Monitor ST-MONITOR Sensitherm Multi Patient Cable ST-PTCBL Sensitherm Multi Adapter ST-ADPT-30 Sensitherm Multi Probe ST-PROBE-5 Sensitherm Multi Probe ST-PROBE-7 FIAB ESOTEST MULTI PATIENT CABLE FIAB ESOTEST MULTI MONITOR FIAB ESOTEST MULTI PROBE FIAB ESOTEST MONITOR, ESOTEST ULTRA FIAB F5406/TER, F5406/ULTRA INTERCONNECT CABLE FIAB ESOTEST PROBE FIAB EURO DEFI PADS FIAB Low Temperatory cautery FIAB ECG PATIENT CABLE FIAB SNAP CONNECTION CABLE FIAB ECG ELECTRODES FIAB ECG ACCESSORIES FIAB High temperature cautery

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-10-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-10-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-11-28
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2013-03-07
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2011-09-16
HQP	Unit, Cautery, Thermal, Battery-Powered	Ophthalmic	Class 2	886.4115	2009-09-03
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2011-09-16
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2012-02-13
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2011-02-08

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Fiab SpA

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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0557-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Z-0564-2021	Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom	2	Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).
Z-0861-2022	Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom	2	Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Z-1825-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Z-2028-2024	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

Similar Registrations

Registration Number	Establishment Name	Location
3017528618	ATRILITY MEDICAL, INC.	Madison, WI, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3030387292	WISE S.p.A.	Cologno Monzese Lombardy, IT
3033919280	DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003072803. Last updated year: 2026. Please use registration number 3003072803 when referencing this establishment in official correspondence.