The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Automatic Digital Blood Pressure Meters, Models.
| Device ID | K912588 |
| 510k Number | K912588 |
| Device Name: | AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEIN ELECTRONICS CO., LTD. C/O THE LAHR CONSULTING GROUP ONE LETHBRIDGE PLAZA, SUITE 7 Mahwah, NJ 07430 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly SEIN ELECTRONICS CO., LTD. C/O THE LAHR CONSULTING GROUP ONE LETHBRIDGE PLAZA, SUITE 7 Mahwah, NJ 07430 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-12-19 |