The following data is part of a premarket notification filed by Seers Technology Co, Ltd with the FDA for Hx-461.
| Device ID | K120545 |
| 510k Number | K120545 |
| Device Name: | HX-461 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEERS TECHNOLOGY CO, LTD 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung SEERS TECHNOLOGY CO, LTD 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-23 |
| Decision Date | 2012-10-23 |
| Summary: | summary |