SMARTez Elastomeric Infusion Pump

Pump, Infusion, Elastomeric

Epic Medical Pte Ltd

The following data is part of a premarket notification filed by Epic Medical Pte Ltd with the FDA for Smartez Elastomeric Infusion Pump.

Pre-market Notification Details

• Device ID: K151650
• 510k Number: K151650
• Device Name: SMARTez Elastomeric Infusion Pump
• Classification: Pump, Infusion, Elastomeric
• Applicant: Epic Medical Pte Ltd 545 Orchard Road, #09-0 Singapore, SG 238882
• Contact: Freddie Lee
• Correspondent: Dave Yungvirt; THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York, NY 10111
• Product Code: MEB
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2015-06-18
• Decision Date: 2016-04-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
98859299101050	K151650	000
10850007185135	K151650	000
10850007185142	K151650	000
10850007185159	K151650	000
10850007185166	K151650	000
10850007185173	K151650	000
00850007185237	K151650	000
10850007185302	K151650	000
10850007185319	K151650	000
10850007185692	K151650	000
10857800006131	K151650	000
10857800006414	K151650	000
10857800006438	K151650	000
10857800006452	K151650	000
10857800006513	K151650	000
48859299100010	K151650	000
48859299100027	K151650	000
10850007185128	K151650	000
10850007185111	K151650	000
98859299101067	K151650	000
98859299101128	K151650	000
98859299101043	K151650	000
98859299101012	K151650	000
98859299101036	K151650	000
10850007185005	K151650	000
10850007185012	K151650	000
10850007185029	K151650	000
10850007185036	K151650	000
10850007185043	K151650	000
10850007185050	K151650	000
10850007185067	K151650	000
10850007185074	K151650	000
10850007185081	K151650	000
10850007185098	K151650	000
10850007185104	K151650	000
48859299100034	K151650	000
48859299100041	K151650	000
48859299104032	K151650	000
48859299104049	K151650	000
48859299104056	K151650	000
58859299101014	K151650	000
58859299101021	K151650	000
58859299101038	K151650	000
58859299101045	K151650	000
58859299101052	K151650	000
58859299101069	K151650	000
58859299101076	K151650	000
58859299101090	K151650	000
58859299101106	K151650	000
58859299101113	K151650	000
58859299101120	K151650	000
58859299101137	K151650	000
58859299101144	K151650	000
48859299104025	K151650	000
48859299104018	K151650	000
48859299100058	K151650	000
48859299100065	K151650	000
48859299100072	K151650	000
48859299100089	K151650	000
48859299100096	K151650	000
48859299100102	K151650	000
48859299100119	K151650	000
48859299100126	K151650	000
48859299100133	K151650	000
48859299100140	K151650	000
48859299100157	K151650	000
48859299100164	K151650	000
48859299100171	K151650	000
48859299100188	K151650	000
48859299100195	K151650	000
48859299101086	K151650	000
58859299101151	K151650	000