The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Impact Blood Pressure System.
| Device ID | K010186 |
| 510k Number | K010186 |
| Device Name: | WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden, NC 28704 |
| Contact | David A Young Ii |
| Correspondent | David A Young Ii WELCH ALLYN, INC. 95 OLD SHOALS RD. Arden, NC 28704 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-06-08 |