The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Spot Ultra Vital Signs Device.
| Device ID | K040490 |
| 510k Number | K040490 |
| Device Name: | WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. Skaneateles Falls, NY 13153 -0220 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-26 |
| Decision Date | 2004-08-18 |
| Summary: | summary |