The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor.
| Device ID | K171621 |
| 510k Number | K171621 |
| Device Name: | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 |
| Contact | Mark Alsberge |
| Correspondent | Mark Alsberge Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-06-30 |
| Summary: | summary |