Fluke Biomedical

FDA Filings

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

Fluke Biomedical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• UNFORS

FDA Registration(s)

• Registration Number: 2921581
• FEI Number: 2921581
• Name: FLUKE BIOMEDICAL
• Owner & Operator: FLUKE ELECTRONICS CORP.
• Contact Address: 6920 SEAWAY BLVD. --; Everett WA 98203 US
• Official Correspondent:
  • Moe - Khosravi
  • x-425-2381137-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 6920 SEAWAY BLVD. ; EVERETT, WA 98203 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K862344 | DRS FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	DPM1B	2018-05-18
PMN K121860 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	ESA615, ESA 614	2013-03-29
PMN K121860 FLUKE BIOMEDICAL	ESA615	2013-01-25
PMN K121722 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	ESA 620	2013-01-03
PMN K121722 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	ESA 612	2013-01-03
PMN K121722 FLUKE BIOMEDICAL	ESA620 ELECTRICAL SAFETY ANALYZER	2012-10-11
PMN K964785 | IYE FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Veridose	2011-12-22
PMN K940660 | IYE FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	37-720 DUAL DIODE DOSIMETRY SYSTEM	2011-12-22
PMN K110429 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	ProSim	2011-12-22
PMN K103336 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Marq III	2011-12-22
PMN K103336 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	MPS450	2011-12-22
PMN K110429 FLUKE BIOMEDICAL	PROSIM 4, PROSIM 6, PROSIM 8	2011-09-02
PMN K103336 FLUKE BIOMEDICAL	MPS450 MULTIPARAMETER SIMULATOR	2011-04-13
PMN K921074 | DXN FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	BP Pump	2010-11-16
PMN K083347 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Impulse 7010	2010-07-27
PMN K072114 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Impulse 7000DP	2008-12-29
PMN K072114 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Impulse 6000D	2008-12-29
PMN K083347 FLUKE BIOMEDICAL	IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS	2008-12-24
PMN K072114 FLUKE BIOMEDICAL	IMPULSE 6000D/7000DP	2008-01-28
PMN K954391 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	QED 6	2007-12-17
PMN K942546 | DXN FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	CUFFLINK NON-INVASIVE BLOOD PRESSUR	2007-12-17
PMN K941404 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Impulse 4000	2007-12-17
PMN K011729 | DTC FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	SIGMAPACE 1000	2007-12-17
KPY FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Clear-Pb	2006-01-25
DRJ FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	SYSTEM, SIGNAL ISOLATION: IT200,IT400,MI800,ML1500-4,ML1500-8	2004-11-09
BXY FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	BXY - FLOWMETER, CALIBRATION, GAS,VT Plus HF, VT305, VT650, VT900 Gas Flow Analyzer and Acculung accessory,QA-VT	2004-11-09
LHO FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	STRUMENTS	1999-12-10
LHO FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	NUCLEAR ASSOCIATES AND VICTOREEN IN	1999-12-10
LHO FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	MULTIPLE FLUKE BIOMEDICAL	1999-12-10
LHO FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	INOVISION	1999-12-10
PMN K973991 | DQA FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	METRON	1997-10-31
PMN K973991 | DQA FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	FLUKE BIOMEDICAL SP02	1997-10-31
PMN K935817 | DRT FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	MedSim300B	1997-02-19
PMN K963190 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	METRON	1994-05-19
PMN K963190 | DRL FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	FLUKE BIOMEDICAL-MULTIPLE	1994-05-19
PMN K982020 | FRN FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	METRON IAGU	1992-12-10
PMN K982020 | FRN FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	FLUKE BIOMEDICAL IAGU	1992-12-10
PMN K963198 | DPS FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	METRON	1992-12-10
PMN K963198 | DPS FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Fluke Biomedical PS420	1992-12-10
PMN K963198 | DPS FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	Fluke Biomedical PS410	1992-12-10
PMN K963198 | DPS FLUKE BIOMEDICAL [FLUKE ELECTRONICS CORP.]	FLUKE BIOMEDICAL-MULTIPLE	1992-12-10

Related Finance Registrations

NCAGE Code	1JZH3	FLUKE BIOMEDICAL!DBA SYNCOR RADIATION MGT LLC
CAGE Code	1JZH3	FLUKE BIOMEDICAL SYNCOR RADIATION MGT LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090335230	Tokyo ,Japan -> Tacoma, Washington	KYOWAGLASXAPLASTIC SHEET HS CODE 3920.59	11 PCS
2020082554127	Tokyo ,Japan -> Tacoma, Washington	KYOWAGLASXAPLASTIC SHEET HS CODE 3920.59	11 PCS
2020082457957	Tokyo ,Japan -> Tacoma, Washington	KYOWAGLASXAPLASTIC SHEET HS CODE 3920.59	11 PCS
2020042439832	Tokyo ,Japan -> Tacoma, Washington	KYOWAGLASXAPLASTIC SHEET HS CODE3920.59	7 PCS
2020032341555	Tokyo ,Japan -> Tacoma, Washington	KYOWAGLASXAPLASTIC SHEET HS CODE3920.59	25 PCS
2020021951018	Tokyo ,Japan -> Tacoma, Washington	KYOWAGLASXAPLASTIC SHEET HS CODE 3920.59	20 PCS