Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006895489

FEI Number

3006895489

Entity Name

MEDIKRO OY

City/State/Country

Kuopio Pohjois-Savo, FI

Establishment Address

Pioneerinkatu 3, Kuopio Pohjois-Savo FI-70800, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medikro Oy (Owner Number: 10047101)

Owner / Operator Contact Address

Pioneerinkatu 3, Kuopio, FI-NOTA FI-70800, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K120577

PMA Number

N/A

All Registered Proprietary Names

M9274, Pressure Tube with grip for SpiroSafe flow transducer M984, Medikro Primo Spirometer with Starter Consumable Pack 410027, SPIROMETRY KIT, CP150 M9256-100, Disposable Flow Transducer, 100 pieces M975, Medikro Pro Spirometer Starter System M915, Medikro Pro Spirometer 720708, WELCH ALLYN USB DATA CABLE 720705, FLOW TRANSDUCERS, SPIRO, 25 PK M914, Medikro Primo Spirometer M9256-SP-90, Disposable Flow Transducer, single packed 90 pieces 720706, FLOW TRANSDUCERS, SPIRO, 100 PK 410370, PRESSURE TUBE & HANDLE, SPIRO M9264-200, Pressure Tube with connectors for Flow Transducer, length 200 cm M9474, Calibration Syringe, volume 3000 ml M974, Medikro Primo Spirometer Starter System M9256-50, Disposable Flow Transducer, 50 pieces 725800, FLOW TRANSDUCERS, SPIRO, 4 PK M985, Medikro Pro Spirometer with Starter Consumable Pack M9256-SP-45, Disposable Flow Transducer, single packed 45 pieces M91227-25, Grip for SpiroSafe flow transducer, single packed 25 pieces 722444, WELCH ALLYN USB DATA CABLE 1.8M 410857, SPIROMETER KIT FOR CONNEX CARDIO M921 Medikro® SpiroStar DX M929 Medikro® SpiroStar USB 703419 Disposable Flow Transducers QTY 100 703552 Spirometer Kit (Serial) M9242-100, SpiroSafe Disposable Flow Transducer M9242-SP-90, SpiroSafe Disposable Flow Transducer 703418 Disposable Flow Transducers QTY 25 703554 Spirometer Kit (USB) 703417 Disposable Flow Transducers QTY 4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2014-06-30
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2015-12-08

Official Correspondent

Mikko Hintikka

US Agent Details

Robert Morton Business: Quality & Regulatory Services, Inc. Email: bob@qrs-i.com Phone: (925) 7872421

Related Public Records

Same Entity

Medikro Oy

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 3006895489. Last updated year: 2026. Please use registration number 3006895489 when referencing this establishment in official correspondence.