The following data is part of a premarket notification filed by Ld Technology Llc with the FDA for Bp-bt Kiosk.
| Device ID | K200287 |
| 510k Number | K200287 |
| Device Name: | BP-BT Kiosk |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LD Technology LLC 100 N. Biscayne Blvd Suite 502 Miami, FL 33132 |
| Contact | Albert Maarek |
| Correspondent | Albert Maarek LD Technology LLC 100 N. Biscayne Blvd Suite 502 Miami, FL 33132 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-05 |
| Decision Date | 2020-05-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B322E0011 | K200287 | 000 |