510(k) K800066
- Device
- NIASTAT
- Applicant
- INVIVO RESEARCH LABS, INC.
- 510(k) number
- K800066
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-02-29
- Date received
- 1980-01-11
- Regulation
- 870.1130
- Classification name
- System, Measurement, Blood-pressure, Non-invasive
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013826848
- 3027645104
- 8022257
- 3011420269
- 3010536822
- 3008573045
- 3016075711
- 2029275
- 3010421104
- 3004415095
- 3013679558
- 3023412068
- 1218950
- 3021131596
- 9611045
- 3009001657
- 3007621003
- 3001034529
- 3010968402
- 3003971136
- 3007583504
- 3006441164
- 3003981912
- 9617543
- 3008011951
- 3003832357
- 3010703925
- 3010838917
- 3016452327
- 3012134907
- 3008264255
- 3011651103
- 3008167616
- 3004101980
- 3006808382
- 3026567235
- 3019130
- 3008164770
- 3027344406
- 3003800159
- 2648727
- 1000122786
- 3013500228
- 1450057
- 2133641
- 3034405508
- 1422443
- 3008395508
- 3042928308
- 3014982318
- 3023272766
- 3010852191
- 3032109181
- 8030476
- 3010317211
- 3013557562
- 3014630021
- 1423537
- 3015109923
- 3008132398
- 3021247088
- 3020848330
- 3008351005
- 9617476
- 2081040
- 3032171377
- 3013543897
- 3004009431
- 1216677
- 3016674095
- 3009499478
- 3005621440
- 3012312061
- 2025816
- 3010395155
- 3021355406
- 3030447506
- 1126271
- 9611031
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DXN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253152 | BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) | Biozen, LLC | 2026-05-06 |
Legacy Summary#
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FDA Review#
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