BODYGUARD INFUSION PUMP SYSTEM

Pump, Infusion

CAESAREA MEDICAL ELECTRONICS LTD.

The following data is part of a premarket notification filed by Caesarea Medical Electronics Ltd. with the FDA for Bodyguard Infusion Pump System.

Pre-market Notification Details

• Device ID: K042696
• 510k Number: K042696
• Device Name: BODYGUARD INFUSION PUMP SYSTEM
• Classification: Pump, Infusion
• Applicant: CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900
• Contact: Gali Tzury
• Correspondent: Gali Tzury; CAESAREA MEDICAL ELECTRONICS LTD. 16 SHACHAM STREET INDUSTRIAL PARK Caesarea, IL 38900
• Product Code: FRN
• Subsequent Product Code: FPA
• Subsequent Product Code: MEA
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-09-30
• Decision Date: 2005-03-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B101A100163XESV0	K042696	000
B101150313XVP0	K042696	000
B101150313XVAR0	K042696	000
B101150313XVA0	K042696	000
B101150313XU0	K042696	000
B101140300XP0	K042696	000
B101140300X0	K042696	000
B101140100X0	K042696	000
B101140000XP0	K042696	000
B101140000X0	K042696	000
B101100919PXIS0	K042696	000
B101100908PTSR0	K042696	000
B101100908PTS0	K042696	000
B101100743XI0	K042696	000
B101150314XU0	K042696	000
B101150314XUP0	K042696	000
B101150314XUR0	K042696	000
B101A100163XESF0	K042696	000
B101A100163XES0	K042696	000
B101A100163XEBS0	K042696	000
B101A100163XEBF0	K042696	000
B101A100163XE90S1	K042696	000
B101190900PXCVP0	K042696	000
B101190900PXCV0	K042696	000
B101190000XGU0	K042696	000
B101150386XR0	K042696	000
B101150386X0	K042696	000
B101150331XP0	K042696	000
B101150317TSR0	K042696	000
B101150317TS0	K042696	000
B101100729PXSR0	K042696	000
B101100729PXS0	K042696	000
B101100516PXSR0	K042696	000
B101100516PXS0	K042696	000
B101100510PXSIR0	K042696	000
B101100510PXSI0	K042696	000
B101100500XAR0	K042696	000
B101100500XA0	K042696	000
B101100500PXR0	K042696	000
B101100500PXA0	K042696	000
B101100500PX0	K042696	000
B101100105TSAR0	K042696	000
B101100105TSA0	K042696	000
10818666020433	K042696	000
B101100500PXE0	K042696	000
B101100517PXS0	K042696	000
B101100517PXSR0	K042696	000
B101100603XSA0	K042696	000
B101100725XSR0	K042696	000
B101100725XS0	K042696	000
B101100620XCVR0	K042696	000
B101100620XCV0	K042696	000
B101100615PXCVR0	K042696	000
B101100615PXCV0	K042696	000
B101100610XCVR0	K042696	000
B101100610XCV0	K042696	000
B101100610PXCVR0	K042696	000
B101100610PXCV0	K042696	000
B101100603XSAR0	K042696	000
B101100603XSAPR0	K042696	000
B101100603XSAP0	K042696	000
00818666020139	K042696	000
B101A100163XSFL0	K042696	000
10818666020365	K042696	000
10818666020198	K042696	000
10818666020181	K042696	000
10818666020174	K042696	000
10818666020167	K042696	000
10818666020150	K042696	000
10818666020143	K042696	000
10818666020129	K042696	000
10818666020068	K042696	000
10818666020051	K042696	000
10818666020044	K042696	000
10818666020037	K042696	000
10818666020020	K042696	000
10818666020013	K042696	000
10818666020204	K042696	000
00818666020214	K042696	000
00818666020221	K042696	000
10818666020358	K042696	000
10818666020341	K042696	000
10818666020334	K042696	000
10818666020327	K042696	000
10818666020310	K042696	000
10818666020303	K042696	000
10818666020297	K042696	000
10818666020280	K042696	000
10818666020273	K042696	000
10818666020266	K042696	000
10818666020259	K042696	000
10818666020242	K042696	000
10818666020235	K042696	000
00818666020009	K042696	000
B101PUMPBG3230	K042696	000
B101A120160CYFRV1	K042696	000
B101A120160CY1	K042696	000
B101A120160CRV1	K042696	000
B101A120160C2YRV1	K042696	000
B101A120160C1	K042696	000
B101A120125XSE1	K042696	000
B101A120125XS1	K042696	000
B101A120112XSFK1	K042696	000
B101A120003XYVA0	K042696	000
B101A120003XSNY1	K042696	000
B101A120003XSN0	K042696	000
B101A120003XS2YV0	K042696	000
B101A100164XESF0	K042696	000
B101A120160CYRV1	K042696	000
B101A120160GCFA0	K042696	000
B101A120160X2YB1	K042696	000
B101A150331X0	K042696	000
B101A120161XYBS1	K042696	000
B101A120161XYB1	K042696	000
B101A120161XPSV1	K042696	000
B101A120161XPS0	K042696	000
B101A120161CYF1	K042696	000
B101A120161C1	K042696	000
B101A120160XYSF1	K042696	000
B101A120160XYBF1	K042696	000
B101A120160XSFK1	K042696	000
B101A120160XSFE1	K042696	000
B101A120160XPSN1	K042696	000
B101A120160XPS1	K042696	000
B101A100163XSL0	K042696	000