The following data is part of a premarket notification filed by Integrated Display Technology, Ltd. with the FDA for Automatic Digital Blood Pressure Monitor.
| Device ID | K942336 |
| 510k Number | K942336 |
| Device Name: | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | INTEGRATED DISPLAY TECHNOLOGY, LTD. 9/F KAISER ESTATE, 41 MAN YUE STREET, HUG HOM, Kowloon, HK |
| Contact | Leo Ng |
| Correspondent | Leo Ng INTEGRATED DISPLAY TECHNOLOGY, LTD. 9/F KAISER ESTATE, 41 MAN YUE STREET, HUG HOM, 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 | 1994-05-16 |
| Decision Date | 1994-11-28 |