Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2434115

FEI Number

2434115

Entity Name

ESSEF DISTRIBUTOR, INC.

City/State/Country

Mineola, NY, US

Establishment Address

264 Herricks Rd, Mineola, NY 11501, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Essef Distributor, Inc. (Owner Number: 10095024)

Owner / Operator Contact Address

264 Herricks Road, Mineola, NY 11501, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182652

PMA Number

N/A

All Registered Proprietary Names

Thermometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2026-01-15

Official Correspondent

Robert Elenowitz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Essef Distributor, Inc.

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

Similar Registrations

Registration Number	Establishment Name	Location
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3009487317	SHENZHEN JUZHONG TECHNOLOGY CO.,LTD	shenzhen Guangdong, CN
9681837	ME CENTER OF TERUMO CORP.	FUJINOMIYA Shizuoka, JP
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2434115. Last updated year: 2026. Please use registration number 2434115 when referencing this establishment in official correspondence.