FLUKE BIOMEDICAL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2921581	2921581	FLUKE BIOMEDICAL	1	Y	2026-01-01	6920 SEAWAY BLVD. EVERETT WA US 98203

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
17366	1620290977	K982020	METRON QA-IDS I.V. PUMP TESTER	FRN	1998-09-30
17366	1860137594	K973991	METRON QA-510 SPO2 ANALYZER	DQA	1998-01-16
17366	1317244148	K964785	VERIDOSE DIODES	IYE	1997-06-13
17366	1835374736	K963198	PS-41 6M PATIENT SIMULATOR	DPS	1997-03-05
17366	1051275265	K963190	QA-40M DEFIBRILLATOR TESTER	DRL	1997-07-01
17366	1421912229	K954391	MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER	DRL	1995-11-17
17366	1023299981	K942546	CUFFLINK NON-INVASIVE BLOOD PRESSURE ANALYZER	DXN	1995-01-27
17366	1104454152	K941404	IMPULSE 4000 DEFIBRILLATOR/TRANSCUTANEOUS PACER ANALYZER	DRL	1994-06-29
17366	1854914568	K940660	MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM	IYE	1994-12-09
17366	1726068903	K935817	MEDSIM 300 PATIENT SIMULATOR	DRT	1994-01-18
17366	1294085164	K921074	BP PUMP	DXN	1992-10-09
17366	1829584396	K862344	GOULD XCALIBER	DRS	1986-08-06
17366	1088205667	K121860	ESA615	DRT	2013-01-25
17366	1746234755	K121722	ESA620 ELECTRICAL SAFETY ANALYZER	DRT	2012-10-11
17366	1818998829	K110429	PROSIM 4, PROSIM 6, PROSIM 8	DRT	2011-09-02
17366	1716349730	K103336	MPS450 MULTIPARAMETER SIMULATOR	DRT	2011-04-13
17366	1766745051	K083347	IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS	DRL	2008-12-24
17366	1938670349	K072114	IMPULSE 6000D/7000DP	DRL	2008-01-28
17366	1695187212	K011729	SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000	DTC	2001-08-30
17366	1167471372
17366	1670266126
17366	1801856630
17366	1603701480

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DRT	5	2013-01-25
DRL	5	2008-12-24
DXN	3	1995-01-27
IYE	2	1997-06-13
DTC	1	2001-08-30
FRN	1	1998-09-30
DQA	1	1998-01-16
DPS	1	1997-03-05
DRS	1	1986-08-06