510(k) K831245
- Device
- TAYLOR PRINTER/AUTO INFLAT-SPHYGMOMANO
- Applicant
- RITTER CO.
- 510(k) number
- K831245
- Product code
- DXN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-19
- Date received
- 1983-04-18
- 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
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3032109181
- 3029987970
- 3006087789
- 3027135885
- 3015007456
- 9617543
- 3014015501
- 1000122786
- 3004835896
- 3013053058
- 3022946813
- 3006113127
- 3016670149
- 3043226252
- 3003591740
- 3020460367
- 3003294644
- 2434008
- 3009155917
- 1036863
- 3005004021
- 3015489159
- 3009560891
- 3021131596
- 3007413079
- 3016674095
- 3016075711
- 3014449259
- 1220649
- 3013896610
- 9680225
- 3022147580
- 3008167616
- 3003703880
- 9615583
- 3024985933
- 3005621440
- 3003764019
- 3005877899
- 3006979678
- 3015531743
- 3009456923
- 1316463
- 3013445220
- 3009077524
- 3009607734
- 3009901017
- 3013557562
- 3014235520
- 3014498861
- 3014601569
- 1450057
- 8010482
- 3003832357
- 3001570235
- 1219324
- 3042156936
- 3004128050
- 3003263092
- 3038280948
- 3033589330
- 3017491419
- 3004918630
- 3005737664
- 9617476
- 3023272766
- 3003193933
- 3014466900
- 3015967131
- 1018233
- 3005798905
- 3015876
- 3035375122
- 2082313
- 3030733800
- 3004832480
- 8031509
- 3011651103
- 3016826509
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases