FDA器械上市前通知/批准

药智数据企业版注册数据库：增设了"联合申报"、"临床试验默认许可日期"等搜索条件，让搜索页面纬度更加全面，还有热点搜索和高级条件组合检索等检索功能等你来体验！

上市前通知

器械名称

申请人

510(K)编号

类型

咨询委员会

收到日

决定日

上市前批准

器械名称

申请人

器械商品名

PMA编号

补编号

咨询委员会

收到日

决定日

注：

列表页默认显示“上市前通知”检索项下的内容；

上市前通知（510(K)）是指通过对拟上市产品与已上市产品在安全性和有效性方面进行比较，在得出实质性等同（Substantial Equivalence，简称SE）结论的前提下，进而获得拟上市产品可以合法销售的上市前通告的一条法规路径，适合于第一类、第二类、少部分三类医疗器械。

上市前批准（PMA）是FDA按照科学性和法规要求，评价第三类医疗器械安全性和有效性的审批程序。

器械名称	申请人	510K号码	类型	医学分类	收到日	决定日
OXYGEN & RESUSCITATION (HOPE II MODEL)	OHIO MEDICAL PRODUCTS	K760101	Traditional		1976-06-23	1976-07-15
FILTER, BACTERIA (#2290)	INSPIRON CORP.	K760081	Traditional	AN	1976-06-21	1976-07-15
CANNULA, NASAL, FOR OXYGEN	INSPIRON CORP.	K760080	Traditional	AN	1976-06-21	1976-07-15
SPONGE, LAPAROTOMY GAUZE	PARKE-DAVIS CO.	K760113	Traditional		1976-06-24	1976-07-15
VALVE, I.M.V. (U-MID ONE WAY)	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC	K760039	Traditional	AN	1976-06-15	1976-07-16
FILTER, I.V., WITH FLASH BULB (#4701)	JELCO LABORATORIES	K760111	Traditional	HO	1976-06-24	1976-07-16
ABSORBER, ANESTHESIA CIRCLE SYS, CO2	FRASER SWEATMAN, INC.	K760076	Traditional	AN	1976-06-18	1976-07-16
TRAY, BLOOD SAMPLING (PULSATOR II)	CONCORD LABORATORIES, INC.	K760086	Traditional	CH	1976-06-21	1976-07-16
FLOWMETER, P.C., REDESIGNED VERSION	OHIO MEDICAL PRODUCTS	K760102	Traditional	AN	1976-06-23	1976-07-16
FILTER, RESPIRATORY (U-MID)	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC	K760041	Traditional	AN	1976-06-15	1976-07-16
KIT, PREP SHAVE	M-C IND., INC.	K760052	Traditional	HO	1976-06-15	1976-07-16
SPECTROPHOTOMETER (JUNIOR III)	THE PERKIN-ELMER CORP.	K760112	Traditional	CH	1976-06-24	1976-07-16
BLOOD WARMER (CODE 4R4305)	TRAVENOL LABORATORIES, S.A.	K760012	Traditional	HE	1976-06-10	1976-07-16
SPONGE, CURITY WASHED GAUZE	KENDALL RESEARCH CENTER	K760094	Traditional	SU	1976-06-21	1976-07-16
FILTER, I.V. (#4700)	JELCO LABORATORIES	K760110	Traditional	HO	1976-06-24	1976-07-16
TEST, RIA, SERUM DIGOXIN	SMITH KLINE DIAGNOSTICS, INC.	K760077	Traditional	TX	1976-06-18	1976-07-16
CAP, INJECTION (#4600)	JELCO LABORATORIES	K760103	Traditional	HO	1976-06-23	1976-07-16
SURGICAL BLADES (BEAVER)	PARKE-DAVIS CO.	K760016	Traditional		1976-06-11	1976-07-16
BOTTLE, CONDENSATE (#1628)	INSPIRON CORP.	K760082	Traditional	HO	1976-06-21	1976-07-16
HEATER, IMMERSION W/ HUMIDIFIER & NEBUL.	INSPIRON CORP.	K760037	Traditional	AN	1976-06-15	1976-07-16