The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Vital Sign Monitor With Mp506.
| Device ID | K024005 |
| 510k Number | K024005 |
| Device Name: | WELCH ALLYN VITAL SIGN MONITOR WITH MP506 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | David Klementowki |
| Correspondent | David Klementowki WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-04 |
| Decision Date | 2003-02-12 |
| Summary: | summary |