K052160 is an FDA 510(k) clearance for the ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.). This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on December 16, 2005, 129 days after receiving the submission on August 9, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K052160 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2005 |
| Decision Date | December 16, 2005 |
| Days to Decision | 129 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |