510(k) K051106

Device: THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS
Applicant: PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH
510(k) number: K051106
Product code: DXN
Decision: Substantially Equivalent (SESE)
Decision date: 2005-07-01
Date received: 2005-05-02
Regulation: 870.1130
Classification name: System, Measurement, Blood-pressure, Non-invasive
Medical specialty: Cardiovascular
Review panel: Cardiovascular
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: HAUKE SCHIK
Address: Hewlett-Packard St. 2 Boeblingen, Baden-Wuerttemberg DE D 71034 D 71034

FDA Registration Numbers#

3037007069
3034603279
3013826848
3038761440
3003622639
3005737664
8030978
3006082230
3007740533
3016867013
3007413079
2648045
2022435
3007154442
3009831876
2221819
3042156936
3003832357
3011353843
3013545943
3010880718
3005536872
1651104
3026567235
3020460367
3014466900
3008780388
3003829675
3044174020
3008164770
3017207990
1220649
3045076243
1832894
3017896172
3022028624
3004415095
3008729547
1000379039
3027510187
3010968402
3013689228
3016075711
3007353620
3015188281
3015309643
3007305624
3012312061
3004594267
8020616
1927197
3028107593
9616164
3006087789
3014774380
3024790242
3006733253
3011912849
3023412068
3010262192
3011200896
3033589330
3012421607
1126271
1423537
3006648320
3014015501
9615817
3004987887
3014449259
2434008
3026753375
3009499478
3013517171
3006169981
3018783526
3013596024
3009690509
3006792041
3011191255

Source Documents#

Other 510(k) Records For Product Code DXN #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K260470	Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)	Shenzhen Brav Electronic Technologies Co., Ltd.	2026-10-01
K261929	Upper Arm Blood pressure monitor (BP7155D)	OMRON Healthcare, Inc.	2026-09-10
K254000	Happy Health Blood Pressure Monitor	Happy Health, Inc.	2026-09-03
K262658	Automatic Digital Blood Pressure monitor (LD-526)	Honsun (Nantong) Co., Ltd.	2026-08-31
K261394	Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)	JOYTECH Healthcare Co., Ltd.	2026-08-26
K253425	Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)	Joytech Healthcare Co. , Ltd.	2026-08-13
K261061	BP Go (BPP-855)	Wellvii, Inc.	2026-08-13
K261082	Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)	Microlife Corporation	2026-07-23
K261136	Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)	Guangzhou Daxin Health Technology Co., Ltd.	2026-07-23
K253126	Wrist Blood Pressure Monitor (XW-05)	Shenzhen Ziqing Medical Equipment Co., Ltd.	2026-06-18
K260693	VicorderCS (VCS-SYS-1100)	80 Beats Medical GmbH	2026-06-16
K253059	Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)	Tournicare Pty, Ltd.	2026-06-15
K253124	Upper arm electronic blood pressure monitor (XB-01)	Shenzhen Ziqing Medical Equipment Co., Ltd.	2026-06-03
K253570	Blood Pressure Monitor (W06LT)	Shenzhen Jamr Technology Co., Ltd.	2026-05-20
K254048	Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)	Shenzhen Urion Technology Co., Ltd.	2026-05-14

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases