The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Blood Pressure Monitor (sphygmomanometer), Model Ht-110.
| Device ID | K012194 |
| 510k Number | K012194 |
| Device Name: | BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 |
| Classification | Blood Pressure Cuff |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 2508-13 NAKAGO KOMOCHI-MURA, KITAGUNMA-GUN Gunma-ken, JP 377-0293 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2001-07-20 |
| Summary: | summary |