Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043047771

FEI Number

3043047771

Entity Name

KYTOLA INSTRUMENTS OY

City/State/Country

Muurame Keski-Suomi, FI

Establishment Address

Olli Kytolan tie 1, Muurame Keski-Suomi 40950, FI

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Kytola Instruments Oy (Owner Number: 10094943)

Owner / Operator Contact Address

Olli Kytolan tie 1, Muurame, FI-08 40950, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

M1006864 Calibration Gas Regulator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2026-01-08

Official Correspondent

Heikki Heiskanen

US Agent Details

Riikka Harkonen Business: Kytola Instruments Inc Email: riikka.harkonen@kytola.com Phone: (678) 4286590

Related Public Records

Same Entity

Kytola Instruments Oy

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2237 Portable 2 Cylinder Manifold Cart, for connecting medical gas cylinders.
Z-0038-2010	Airgas Puritan Medical Puritan Medical Unit	1	AGI-2238 Portable 4 Cylinder Manifold Cart, for connecting medical gas cylinders.

Similar Registrations

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1062191	Inovo Inc.	Lehigh Acres, FL, US
1924066	Allied Medical LLC	Earth City, MO, US
3020460367	BOUND TREE MEDICAL, LLC	Grand Prairie, TX, US
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043047771. Last updated year: 2026. Please use registration number 3043047771 when referencing this establishment in official correspondence.