The following data is part of a premarket notification filed by Integrated Display Technology, Ltd. with the FDA for Digital Blood Pressure Meter - Model No.: Bpm883.
| Device ID | K951977 |
| 510k Number | K951977 |
| Device Name: | DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | INTEGRATED DISPLAY TECHNOLOGY, LTD. 9F KAISER ESTATE 41 YUE STREET Hunghom, Kowloon, HK |
| Contact | Leo Nh |
| Correspondent | Leo Nh INTEGRATED DISPLAY TECHNOLOGY, LTD. 9F KAISER ESTATE 41 YUE STREET Hunghom, Kowloon, HK |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-10-24 |