Medikro Oy

FDA Filings

This page includes the latest FDA filings for Medikro Oy. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006895489
FEI Number3006895489
NameRobert Morton
Owner & OperatorMedikro Oy
Contact AddressPioneerinkatu 3
Kuopio FI-NOTA FI-70800 FI
Official Correspondent
  • Mikko Hintikka
  • 358-44-7777002-x
US Agent
Importing Logistics Registration
ImporterPrimary Care Diagnostics LLC
Address330 Jimmy Johnston Road
Greeneville, TN 37743 UNITED STATES
Phone1 423 9142986
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1244 Fairway Valley Ct
Lincoln, CA 95648 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Medikro Oy
M9256-PCD, Disposable Flow Transducer, 100 pcs 2020-03-23
Medikro Oy
M9256, SpiroSafe Disposable Flow Transducer 2020-03-23
Medikro Oy
M9256, SpiroSafe Disposable Flow Transducer 2020-03-23
Medikro Oy
M9264-PCD-200, Pressure Tube 2019-12-09
Medikro Oy
M915-PCD, PCD Spirometer Kit 2019-12-09
Medikro Oy
M91227-25, Medikro® Grip 2018-08-13
Medikro Oy
M9227, Nose Clip 2018-08-13
Medikro Oy
M915, Medikro® Pro 2018-08-13
Medikro Oy
M914, Medikro® Primo 2018-08-13
Medikro Oy
M913, Medikro® Nano 2018-08-13
Medikro Oy
M9264-200, Pressure Tube 2018-08-13
Medikro Oy
M9474, Medikro® Calibration Syringe, 3000 ml 2018-08-13
Robert Morton [Medikro Oy]
M929 Medikro? SpiroStar USB2015-12-08
Robert Morton [Medikro Oy]
M9242-SP-90, SpiroSafe Disposable Flow Transducer2015-12-08
Robert Morton [Medikro Oy]
M9242-100, SpiroSafe Disposable Flow Transducer2015-12-08
Robert Morton [Medikro Oy]
M921 Medikro? SpiroStar DX2015-12-08
Robert Morton [Medikro Oy]
703554 Spirometer Kit (USB)2015-12-08
Robert Morton [Medikro Oy]
703552 Spirometer Kit (Serial)2015-12-08
Robert Morton [Medikro Oy]
703419 Disposable Flow Transducers QTY 1002015-12-08
Robert Morton [Medikro Oy]
703418 Disposable Flow Transducers QTY 252015-12-08
Robert Morton [Medikro Oy]
703417 Disposable Flow Transducers QTY 42015-12-08
MEDIKRO OY
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB And M921 Medikro SpiroStar DX2015-06-24
Robert Morton [Medikro Oy]
M985, Medikro Pro Spirometer with Starter Consumable Pack2014-06-30
Robert Morton [Medikro Oy]
M984, Medikro Primo Spirometer with Starter Consumable Pack2014-06-30
Robert Morton [Medikro Oy]
M983, Medikro Nano Spirometer with Starter Consumable Pack2014-06-30
Robert Morton [Medikro Oy]
M983+911, Medikro Nano Spirometer with Starter Consumable Pack and Medikro Ambi2014-06-30
Robert Morton [Medikro Oy]
M975, Medikro Pro Spirometer Starter System2014-06-30
Robert Morton [Medikro Oy]
M974, Medikro Primo Spirometer Starter System2014-06-30
Robert Morton [Medikro Oy]
M973, Medikro Nano Spirometer Starter System2014-06-30
Robert Morton [Medikro Oy]
M973+911, Medikro Nano Spirometer Starter System with Medikro Ambi2014-06-30
Robert Morton [Medikro Oy]
M9477, Calibration Syringe, volume 1000 ml2014-06-30
Robert Morton [Medikro Oy]
M9474, Calibration Syringe, volume 3000 ml2014-06-30
Robert Morton [Medikro Oy]
M9274, Pressure Tube with grip for SpiroSafe flow transducer2014-06-30
Robert Morton [Medikro Oy]
M9264-200, Pressure Tube with connectors for Flow Transducer, length 200 cm2014-06-30
Robert Morton [Medikro Oy]
M9256-SP-90, Disposable Flow Transducer, single packed 90 pieces2014-06-30
Robert Morton [Medikro Oy]
M9256-SP-45, Disposable Flow Transducer, single packed 45 pieces2014-06-30
Robert Morton [Medikro Oy]
M9256-50, Disposable Flow Transducer, 50 pieces2014-06-30
Robert Morton [Medikro Oy]
M9256-100, Disposable Flow Transducer, 100 pieces2014-06-30
Robert Morton [Medikro Oy]
M9227-100, Nose clip, 100 pieces2014-06-30
Robert Morton [Medikro Oy]
M915, Medikro Pro Spirometer2014-06-30
Robert Morton [Medikro Oy]
M914, Medikro Primo Spirometer2014-06-30
Robert Morton [Medikro Oy]
M913, Medikro Nano Spirometer2014-06-30
Robert Morton [Medikro Oy]
M91227-25, Grip for SpiroSafe flow transducer, single packed 25 pieces2014-06-30
Robert Morton [Medikro Oy]
M911, Medikro Ambi Ambient Measurement Unit2014-06-30
Robert Morton [Medikro Oy]
725800, FLOW TRANSDUCERS, SPIRO, 4 PK2014-06-30
Robert Morton [Medikro Oy]
722444, WELCH ALLYN USB DATA CABLE 1.8M2014-06-30
Robert Morton [Medikro Oy]
720854, NOSE CLIP2014-06-30
Robert Morton [Medikro Oy]
720708, WELCH ALLYN USB DATA CABLE2014-06-30
Robert Morton [Medikro Oy]
720706, FLOW TRANSDUCERS, SPIRO, 100 PK2014-06-30
Robert Morton [Medikro Oy]
720705, FLOW TRANSDUCERS, SPIRO, 25 PK2014-06-30
Robert Morton [Medikro Oy]
410857, SPIROMETER KIT FOR CONNEX CARDIO2014-06-30
Robert Morton [Medikro Oy]
410370, PRESSURE TUBE & HANDLE, SPIRO2014-06-30
Robert Morton [Medikro Oy]
410027, SPIROMETRY KIT, CP1502014-06-30
MEDIKRO OY
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO2014-05-21

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