The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Wrist Blood Pressure Meter Model Se-330.
| Device ID | K973078 |
| 510k Number | K973078 |
| Device Name: | WRIST BLOOD PRESSURE METER MODEL SE-330 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | SEIN ELECTRONICS CO., LTD. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 -2113 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly SEIN ELECTRONICS CO., LTD. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 -2113 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1999-05-20 |
| Summary: | summary |