PULMONE USA INC

FDA Device Registration & Listing · Carrollton, TX, US · Registration 3011583549

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011583549
FEI Number
3011583549
Entity Name
PULMONE USA INC
City/State/Country
Carrollton, TX, US
Establishment Address
4100 Medical Pkwy Ste 200, Carrollton, TX 75007, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
PulmOne USA INC (Owner Number: 10049302)
Owner / Operator Contact Address
3740 N. Josey Lane, Suite 244, Carrollton, TX 75007, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K161295
PMA Number
N/A

All Registered Proprietary Names

MiniBox+

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2025-07-27
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2025-07-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011583549. Last updated year: 2026. Please use registration number 3011583549 when referencing this establishment in official correspondence.
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