Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013744763

FEI Number

3013744763

Entity Name

NUVOAIR AB

City/State/Country

Stockholm, SE

Establishment Address

Riddargatan 17D, 3 tr, Stockholm 11457, SE

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

NuvoAir AB (Owner Number: 10063987)

Owner / Operator Contact Address

Riddargatan 17D, 3 tr, Stockholm, SE-AB 11457, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231416

PMA Number

N/A

All Registered Proprietary Names

Air Next Air Next

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2020-03-23
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-02-07

Official Correspondent

Mircea Campian

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

NuvoAir AB

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 3013744763. Last updated year: 2026. Please use registration number 3013744763 when referencing this establishment in official correspondence.