The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Dm-3000 Digital Blood Pressure Monitor.
| Device ID | K061086 |
| 510k Number | K061086 |
| Device Name: | DM-3000 DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 106 EAST 5TH AVENUE Mount Dora, FL 32757 |
| Contact | Lynette Howard |
| Correspondent | KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-18 |
| Decision Date | 2006-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00634782595654 | K061086 | 000 |
| 00634782064983 | K061086 | 000 |
| 00634782857660 | K061086 | 000 |
| 00634782057893 | K061086 | 000 |
| 00634782057909 | K061086 | 000 |
| 00634782059774 | K061086 | 000 |
| 00634782062965 | K061086 | 000 |
| 00634782570552 | K061086 | 000 |
| 00634782070892 | K061086 | 000 |
| 00634782570576 | K061086 | 000 |
| 00634782057855 | K061086 | 000 |