510(k) K140412
- Device
- ANS1 SOFTWARE
- Applicant
- LD TECHNOLOGY LLC
- 510(k) number
- K140412
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-22
- Date received
- 2014-02-18
- 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
- ALBERT MAAREK
- Address
- 100 Biscayne Blvd. Suite 502 Miami FL US 33132 33132
FDA Registration Numbers#
- 3011353843
- 3008365372
- 3011654863
- 3032948391
- 3003764019
- 3012725363
- 3019130
- 3017075369
- 3013500228
- 3034405508
- 8010482
- 8030245
- 3045076243
- 3005783425
- 3010968402
- 3017493034
- 9617127
- 3005004021
- 3006441164
- 3011790297
- 3007154442
- 3009155917
- 3031259044
- 3014736845
- 3030671608
- 3014601569
- 3010405299
- 3020460367
- 3017406171
- 2030598
- 3015181391
- 3013596024
- 3016618143
- 9615583
- 9710602
- 3020848330
- 3003687189
- 3017422354
- 3038620598
- 3030447506
- 3004987887
- 3035375122
- 3014235520
- 3011721071
- 9615817
- 3013689228
- 3020160672
- 3023412068
- 3004485927
- 3005621440
- 3009889471
- 3004727197
- 3003803088
- 3043513123
- 1651104
- 3006733253
- 1018233
- 3010421104
- 1066444
- 9617476
- 2081040
- 3006793151
- 3009831876
- 3006950086
- 1319390
- 3011200896
- 9616164
- 3019470217
- 3010390468
- 3006852037
- 2011171
- 3015309643
- 9617594
- 3005737664
- 3026585241
- 2032112
- 3008164770
- 1120986
- 2412762
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | 2026-04-01 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | 2026-03-26 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-03-05 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2026-02-23 |
Legacy Summary#
summary
FDA Review#
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