The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Device Connectivity Software Developers Kit (sdk), Model 4500-900.
| Device ID | K052784 |
| 510k Number | K052784 |
| Device Name: | DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 |
| 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 | Chris Klaczky |
| Correspondent | Chris Klaczky 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2005-11-22 |
| Summary: | summary |