The following data is part of a premarket notification filed by Welch Allyn Protocol, Inc. with the FDA for Modification To Acuity Central Monitoring System.
| Device ID | K022453 |
| 510k Number | K022453 |
| Device Name: | MODIFICATION TO ACUITY CENTRAL MONITORING SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Contact | Don M Abbey |
| Correspondent | Don M Abbey WELCH ALLYN PROTOCOL, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7107 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2002-08-21 |
| Summary: | summary |