510(k) K101275
- Device
- MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCH BP OFFICE AFIB (TWIN200 AFS).
- Applicant
- MICROLIFE INTELLECTUAL PROPERTY GMBH
- 510(k) number
- K101275
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2010-05-28
- Date received
- 2010-05-06
- 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
- SUSAN D GOLDSTEIN-FALK
- Address
- 55 Northern Blvd., Suite 200 Great Neck NY US 11021 11021
FDA Registration Numbers#
- 3022147580
- 9615817
- 9616164
- 3021635975
- 2648727
- 3027510187
- 3010419931
- 1450057
- 1054421
- 3012359877
- 3032916632
- 3015522053
- 3005536872
- 3008167616
- 3042928308
- 3017303999
- 3011721071
- 3013543897
- 3017894657
- 3003764019
- 3006808382
- 3018940143
- 3026567235
- 3017520431
- 3006113127
- 3045076243
- 3004727093
- 3012312061
- 3005004021
- 3016707048
- 3019470217
- 1419898
- 3008507279
- 3007384659
- 3014982318
- 3008011951
- 8030978
- 3009889471
- 3006258337
- 3007420856
- 2133641
- 3005737664
- 3010157426
- 3027645104
- 3016445583
- 3006636961
- 3003981912
- 3015455735
- 3008975047
- 3008164770
- 3017500903
- 3013920399
- 3021131596
- 3004145393
- 3003993690
- 3011420269
- 3037007069
- 1651104
- 8020605
- 3032013079
- 3004415095
- 3009456923
- 3016618143
- 3022946813
- 3003591740
- 3026585241
- 3004832480
- 3001570235
- 3024985933
- 3013319763
- 9616390
- 3022418645
- 3031259044
- 3032109181
- 3032171377
- 3012251275
- 3029987970
- 3008132398
- 3006441164
Source Documents#
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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