The following data is part of a premarket notification filed by Idt Technology Limited with the FDA for Blood-pressure Meter, Bpw120.
| Device ID | K050083 |
| 510k Number | K050083 |
| Device Name: | BLOOD-PRESSURE METER, BPW120 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | IDT TECHNOLOGY LIMITED BLOCK C, 9/F., KAISER ESTATE, PHASE 1, 41 MAN YUE STREET Hunghom, HK |
| Contact | Leon Leong |
| Correspondent | Leon Leong IDT TECHNOLOGY LIMITED BLOCK C, 9/F., KAISER ESTATE, PHASE 1, 41 MAN YUE STREET Hunghom, HK |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-13 |
| Decision Date | 2005-04-08 |