510(k) K120320
- Device
- CONNECTED CARE CLINICAL APPLICATION
- Applicant
- WATERMARK MEDICAL INC
- 510(k) number
- K120320
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-08-14
- Date received
- 2012-02-02
- Regulation
- 870.1130
- Classification name
- System, Measurement, Blood-pressure, Non-invasive
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL J LEIGH
- Address
- 1117 Perimeter Ctr W Suite W514 Atlanta GA US 30338 30338
FDA Registration Numbers#
- 1927197
- 3007134734
- 3007353620
- 3013561145
- 1430016
- 3008925277
- 3009001657
- 3017953405
- 9617476
- 3013557562
- 3032916632
- 3011654863
- 3009617411
- 8030978
- 3016707048
- 1220649
- 9680548
- 3020160672
- 3019130
- 3006082230
- 3012302888
- 3013920399
- 3015619973
- 2011171
- 3016630774
- 3003803088
- 3032013079
- 3011912849
- 3003687189
- 1218950
- 3017424877
- 3010317211
- 3013445220
- 9615817
- 1062836
- 9710654
- 3015876
- 3004871905
- 3012134907
- 3013298431
- 3021422553
- 3017406171
- 3011651103
- 3034603279
- 3011359729
- 9680215
- 3001570235
- 3004485927
- 3016601021
- 3003591740
- 3008395508
- 3003832357
- 3017894657
- 3014466900
- 3044174020
- 3005877899
- 3013500228
- 3014166838
- 3004918630
- 3003500271
- 8031509
- 3037724692
- 3013545943
- 9616164
- 9611045
- 3017520431
- 3003864328
- 3015188281
- 3010405299
- 3004977335
- 1018233
- 3015058854
- 3003657019
- 3007836437
- 3035375122
- 3006169981
- 3015136472
- 3006769302
- 3014736845
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026-05-06 |
| K252501 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) | Joytech Healthcare Co. , Ltd. | 2026-04-28 |
| K260260 | Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) | Honsun (Nantong) Co., Ltd. | 2026-04-28 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | 2026-04-21 |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | 2026-04-01 |
Legacy Summary#
summary
FDA Review#
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