The following data is part of a premarket notification filed by Little Doctor (shanghai) Electronic with the FDA for Ld-578 Fully Automatic Digital Blood Pressure Monitor.
| Device ID | K061279 |
| 510k Number | K061279 |
| Device Name: | LD-578 FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | LITTLE DOCTOR (SHANGHAI) ELECTRONIC 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk LITTLE DOCTOR (SHANGHAI) ELECTRONIC 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-08-18 |
| Summary: | summary |