RESMED

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
		ResMed Malaysia Operations Sdn Bhd	5	N	2026-01-01	No 80&81, Jalan I-Park SAC 5, Taman Perindustrian I-Park Senai Johor MY 81400
3007009701	3007009701	ResMed West Coast Warehouse	1	Y	2026-01-01	24960 San Michele Rd Moreno Valley CA US 92551
3007573469	1000115734	RESMED CORP	1	Y	2026-01-01	9001 Spectrum Center Boulevard San Diego CA US 92123
3011205710	3011205710	ResMed Corp	1	Y	2026-01-01	600 Riverside Parkway Suite 100 Lithia Spgs GA US 30122
3007327600	3007327600	ResMed Asia Pte. Ltd.	1	N	2020-04-25	8 Loyang Crescent No. 05 - 01 Singapore Not Applicable SG 509016

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
101579	1194118649	K984428	SULLIVAN AUTOSET NASAL CPAP SYSTEM	BZD	1999-07-26
101579	1685607997	K961783	SULLIVAN VPAP II ST NASAL VPAP SYSTEM	BZD	1996-08-01
101579	2069382066	K251661	Mariana Minerva; Mariana Nimbus	MNS	2026-02-23
101579	1130731977	K241939	EasyCare Tx 2	BZD	2024-09-27
101579	1768531164	K241216	myAir	BZD	2024-09-26
101579	1924125193	K234134	AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System	BZD	2024-09-24
101579	1367798296	K220028	NightOwl	MNR	2022-02-24
101579	1558832341	K203126	S10 Kirra	BZD	2020-12-18
101579	1688952818	K200565	Galapogos	BZD	2021-01-17
101579	1627869952	K200564	Aria System	JOW	2020-04-03
94458	2056652443	K183512	Moore Park Mask	BZD	2019-05-07
101579	2056652443	K183512	Moore Park Mask	BZD	2019-05-07
94458	1138158284	K180497	Scone Mask	BZD	2018-06-15
101579	1138158284	K180497	Scone Mask	BZD	2018-06-15
101579	1483821880	K172875	Astral 100/150	CBK	2018-04-26
94458	2049858372	K171212	AirFit N20	BZD	2017-09-28
101579	2049858372	K171212	AirFit N20	BZD	2017-09-28
94458	1033221944	K170924	AirFit F20	BZD	2018-01-03
101579	1033221944	K170924	AirFit F20	BZD	2018-01-03
94458	1397150670	K161978	AirFit N20	BZD	2016-11-17
101579	1397150670	K161978	AirFit N20	BZD	2016-11-17
101579	1441837889	K161492	Juno VPAP ST-A	MNS	2017-01-19
101579	1960806420	K160836	Menai System	BZD	2016-12-15
94458	1177362491	K153673	AirFit N20	BZD	2016-05-02
101579	1177362491	K153673	AirFit N20	BZD	2016-05-02
94458	1519521336	K153563	AirFit F20	BZD	2016-05-13
101579	1519521336	K153563	AirFit F20	BZD	2016-05-13
94458	2061228260	K153061	Juno VPAP ST-A	MNS	2016-04-13
101579	2061228260	K153061	Juno VPAP ST-A	MNS	2016-04-13
101579	1286910236	K152068	Astral 100/150	CBK	2016-05-13
101579	1298224757	K151901	AirView	CBK	2015-11-05
101579	1756959924	K143603	Darlinghurst Vented, Darlinghurst NV-AAV	BZD	2015-05-21
101579	2037230504	K143272	ApneaLink Air	MNR	2015-04-30
94458	1873397802	K140279	S9 GREENHILLS	BZD	2014-07-31
101579	1873397802	K140279	S9 GREENHILLS	BZD	2014-07-31
94458	1591373970	K140159	S9 WANDA VPAP ST	BZD	2014-06-17
101579	1591373970	K140159	S9 WANDA VPAP ST	BZD	2014-06-17
94458	1439023676	K140124	S9 ELOUERA	BZD	2014-05-12
101579	1439023676	K140124	S9 ELOUERA	BZD	2014-05-12
101579	1437469262	K140054	RESCAN	BZD	2014-05-16
101579	1856215600	K133868	ASTRAL VENTILATOR	CBK	2014-06-04
94458	1450117624	K132887	AIRFIT N10	BZD	2013-12-20
101579	1450117624	K132887	AIRFIT N10	BZD	2013-12-20
101579	2031536152	K132371	EASYCARE ONLINE	MNS	2013-11-22
94458	1521652490	K132205	ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM	CAW	2014-06-06
101579	1521652490	K132205	ACTOVOX DUO2 OXYGEN CONCENTRATOR SYSTEM	CAW	2014-06-06
94458	1841125675	K132013	SWIFT AIR	BZD	2013-10-21
101579	1841125675	K132013	SWIFT AIR	BZD	2013-10-21
94458	1102885368	K123979	QUATTRO AIR	BZD	2013-02-27
94458	1374094236	K123789	SWIFT FX NANO	BZD	2013-03-29
101579	1374094236	K123789	SWIFT FX NANO	BZD	2013-03-29
101579	1608530166	K123511	S9 VPAP TX	MNS	2013-03-21
101579	2000287705	K122715	STELLAR 150	MNT	2013-06-17
101579	1466884958	K122324	VPAP S-A	MNS	2012-11-13
101579	1138220490	K113780	EASYCARE TX SYSTEM (CONNEXUNS)	BZD	2012-04-20
101579	1112048222	K113714	VPAP TX	MNS	2012-05-25
101579	1085948649	K113640	STELLAR 150	MNT	2012-04-05
94458	1751314334	K113317	LIFECHOICE OXYGEN CONCENTRATOR	CAW	2011-12-28
101579	1751314334	K113317	LIFECHOICE OXYGEN CONCENTRATOR	CAW	2011-12-28
101579	1143755059	K113288	VPAP ST-A	MNS	2012-03-29
101579	1379260229	K113127	MIRAGE QUATTRO	BZD	2012-01-06
101579	1861004543	K112914	VPAP TX	MNS	2011-12-29
94458	1569142828	K112489	SWIFT FX BELLA	BZD	2011-12-07
101579	1569142828	K112489	SWIFT FX BELLA	BZD	2011-12-07
101579	1378192407	K111148	S8 ASPEN WITH H4I PLUS	BZD	2011-06-30
101579	1179495509	K103167	STELLAR 150	MNT	2011-03-01
94458	1288363342	K102746	MIRAGE FX	BZD	2010-12-28
101579	1288363342	K102746	MIRAGE FX	BZD	2010-12-28
101579	1302600627	K102586	S9 VPAP ADAPT WITH H5I	BZD	2011-03-18
94458	1895672128	K102513	S9 VPAP ST WITH H5I	BZD	2011-01-05
101579	1895672128	K102513	S9 VPAP ST WITH H5I	BZD	2011-01-05
101579	2033285655	K102224	PIXI PEDIATRIC MASK	BZD	2010-12-10
101579	1441010496	K093731	VPAP III ST-A	MNS	2010-03-22
101579	1243172442	K092186	VPAP TX	MNS	2009-12-22
94458	1520855923	K091947	S8 ASPEN WITH H4I PLUS	BZD	2009-09-28
101579	1520855923	K091947	S8 ASPEN WITH H4I PLUS	BZD	2009-09-28
94458	1870115846	K091129	QUATTRO LT	BZD	2009-08-03
101579	1870115846	K091129	QUATTRO LT	BZD	2009-08-03
101579	1200250660	K090490	MIRAGE ECHO	BZD	2009-05-06
94458	1669564388	K090244	SWIFT FX	BZD	2009-04-13
101579	1669564388	K090244	SWIFT FX	BZD	2009-04-13
101579	1533465791	K080131	VPAP ST	BZD	2008-04-01
94458	1543181528	K073638	SWIFT LT	BZD	2008-03-20
101579	1543181528	K073638	SWIFT LT	BZD	2008-03-20
101579	1730954488	K072940	MIRAGE MICRO	BZD	2007-12-13
94458	2049252080	K072688	LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000	CAW	2008-01-11
101579	2049252080	K072688	LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000	CAW	2008-01-11
101579	1692868947	K071171	VPAP AUTO WITH H3I	BZD	2007-07-10
94458	1530176126	K063122	MIRAGE QUATTRO FULL FACE MASK	BZD	2007-02-02
94458	1801191435	K063011	MIRAGE LIBERTY FULL FACE MASK	BZD	2007-02-02
101579	1801191435	K063011	MIRAGE LIBERTY FULL FACE MASK	BZD	2007-02-02
101579	1702404339	K060105	VPAP III ST-A/KIDSTA MASK SYSTEM	MNS	2006-04-07
94458	1336250306	K050359	ULTRA MIRAGE II MASK	BZD	2005-03-16
101579	1336250306	K050359	ULTRA MIRAGE II MASK	BZD	2005-03-16
94458	1745819187	K042403	MIRAGE SWIFT	BZD	2004-10-08
101579	1745819187	K042403	MIRAGE SWIFT	BZD	2004-10-08
101579	1616773832	K041362	RESMED HOSPITAL FULL FACE MASK	BZD	2004-07-15
101579	1014772869	K041209	RESMED S8 PIONEER CPAP SYSTEM	BZD	2004-07-01
101579	1737194333	K040566	RESMED HOSPITAL NASAL MASK	BZD	2004-04-02
101579	1565153570	K032916	MIRAGE ACTIVA MASK	BZD	2003-12-04
101579	1499253684	K031047	MIRAGE VISTA MASK	BZD	2003-08-19
94458	1245881609	K023306	MIRAGE FULL FACE MASK SERIES 2	BZD	2002-11-27
101579	1245881609	K023306	MIRAGE FULL FACE MASK SERIES 2	BZD	2002-11-27
174872	1033221944
101579	1044796922
349763	1044796922
88762	1098933778
101579	1098933778
174872	1098933778
349763	1102885368
174872	1138158284
349763	1138158284
101579	1159116240
349763	1159116240
101579	1195330398
349763	1195330398
101579	1198681730
349763	1234053060
101579	1253492208
174872	1286910236