510(k) K173916
- Device
- Finapres Nova Noninvasive Hemodynamic Monitor
- Applicant
- Finapres Medical Systems B.V.
- 510(k) number
- K173916
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-11-06
- Date received
- 2017-12-22
- 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
- Iris van Uitert
- Address
- Institutenweg 25 Enschede NL 7521 PH 7521 PH
FDA Registration Numbers#
- 3044174020
- 3016640651
- 3008132398
- 3013319763
- 3017887928
- 3013298431
- 3012312061
- 3027645104
- 3004022358
- 3032171377
- 3015522053
- 3005798905
- 9680215
- 3042579404
- 3011191255
- 3004145393
- 1220908
- 3035375122
- 3004918630
- 3011200896
- 3015236197
- 3018783526
- 3013053058
- 9615817
- 3035111606
- 3004101980
- 3009889471
- 3021343210
- 3021247088
- 8010482
- 3017858797
- 3008395508
- 2221819
- 3012528160
- 3016867013
- 2133641
- 3003687189
- 3029987970
- 3021282523
- 1062836
- 9611045
- 3012104670
- 3009155917
- 3017500903
- 3006636961
- 3014015501
- 3015181391
- 3005536872
- 3022764531
- 3010381606
- 3012359877
- 3021559257
- 3014541700
- 2025816
- 3005783425
- 3014774380
- 3001570235
- 3016618143
- 3026585241
- 3006648320
- 3019130
- 3017894657
- 3009499478
- 3010288146
- 3010419931
- 1126271
- 3016452327
- 3009327812
- 3013596024
- 3005941719
- 3016931915
- 9617594
- 3003993690
- 8020616
- 1523530
- 1417592
- 3015455735
- 3010317211
- 3006808382
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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