Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011269086

FEI Number

3011269086

Entity Name

PULMONE ADVANCED MEDICAL DEVICES, LTD.

City/State/Country

Raananna Central, IL

Establishment Address

14 HaMelacha Street, Raananna Central 4366107, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PulmOne Advanced Medical Devices, Ltd. (Owner Number: 10049235)

Owner / Operator Contact Address

14 HaMelacha Street, Raananna, IL-M 4366107, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K141793

PMA Number

N/A

All Registered Proprietary Names

MiniBox+ MiniBox

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2016-12-06
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2016-12-06
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2015-05-01
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2015-05-01

Official Correspondent

Shlomo Daler

US Agent Details

Jared Paioff Business: Schwartz Sladkus Reich Greenberg Atlas LLP Email: jpaioff@ssrga.com Phone: (212) 7437025

Related Public Records

Same Entity

PulmOne Advanced Medical Devices, Ltd.

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
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09

Similar Registrations

Registration Number	Establishment Name	Location
3036774597	TECHNOPULM, LTD.	Petah Tikva Central, IL
3016701404	Philips North America LLC	Export, PA, US
1216677	COOPERSURGICAL, INC.	Trumbull, CT, US
2183022	MEDICAL GRAPHICS CORP.	Saint Paul, MN, US
3012528160	Philips North America LLC	Murrysville, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011269086. Last updated year: 2026. Please use registration number 3011269086 when referencing this establishment in official correspondence.