The following data is part of a premarket notification filed by Padtest, Llc with the FDA for Padcheck.
| Device ID | K093205 |
| 510k Number | K093205 |
| Device Name: | PADCHECK |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | PADTEST, LLC 801 SOUTH GRAND AVENUE #1907 Los Angeles, CA 90017 |
| Contact | James R Greenwood |
| Correspondent | James R Greenwood PADTEST, LLC 801 SOUTH GRAND AVENUE #1907 Los Angeles, CA 90017 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-13 |
| Decision Date | 2010-04-01 |
| Summary: | summary |