KB Components Finland Oy

FDA Device Registration & Listing · Nurmijarvi Etela-Karjala, FI · Registration 3004415070

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
3004415070
FEI Number
3004415070
Entity Name
KB Components Finland Oy
City/State/Country
Nurmijarvi Etela-Karjala, FI
Establishment Address
Ilvestie 5, Nurmijarvi Etela-Karjala 01900, FI
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
KB Components Finland Oy (Owner Number: 10032433)
Owner / Operator Contact Address
Ilvestie 5, Nurmijarvi, FI-NOTA 01900, FI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

D-lite++ PATIENT SPIROMETRY SET, 3M/10FT, 20 PCS/PKG D-lite++ PATIENT SPIROMETRY SET, 2M/7FT, 20 PCS/PKG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHQ Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-09-27
CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm) Anesthesiology Class 2 868.2600 2023-09-27
NHO Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-09-27
CCL Analyzer, Gas, Oxygen, Gaseous-Phase Anesthesiology Class 2 868.1720 2023-09-27
CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1620 2023-09-27
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-09-27
CBQ Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-09-27
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) Anesthesiology Class 2 868.1500 2023-09-27
BZK Spirometer, Monitoring (W/Wo Alarm) Anesthesiology Class 2 868.1850 2023-09-27
CBR Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) Anesthesiology Class 2 868.1700 2023-09-27
BZL Computer, Oxygen-Uptake Anesthesiology Class 2 868.1730 2023-09-27

Official Correspondent

Mindy McCann

US Agent Details

Mindy McCann Business: Qserve Group US, Inc. Email: usagent@qservegroup.com Phone: (424) 2718169

Related Public Records

Same Entity

KB Components Finland 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
K812140 3M Company BIRD MEAN AIRWAY PRESSURE MONITOR 1981-08-20
K072469 Digiflo, Inc. DIGIFLO CONCENTRATOR ANALYZER 2008-01-03
K142467 Abeon Medical Corporation IntelAir Nasal Airway Support System 2014-11-24
K861213 Datex Division Instrumentarium Corp. PB 254 IR - SPECTROMETER 1986-04-04
K172904 Philips Medizin Systeme Boeblingen GmbH IntelliVue Capnography Extension, IntelliVue Microstream Extension 2017-12-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01
Z-0027-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004415070. Last updated year: 2026. Please use registration number 3004415070 when referencing this establishment in official correspondence.
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