The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Connex Central Station.
Device ID | K212473 |
510k Number | K212473 |
Device Name: | Welch Allyn Connex Central Station |
Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
Applicant | Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 |
Contact | Megan Pellenz |
Correspondent | Megan Pellenz Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 |
Product Code | MWI |
CFR Regulation Number | 870.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-06 |
Decision Date | 2022-10-28 |