The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Acuity Central Station, Model 020xxxxx (note: Xxxxx = Various Config.).
| Device ID | K052160 |
| 510k Number | K052160 |
| Device Name: | ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. Skaneateles Falls, NY 13153 -0220 |
| Contact | John E Sawyer |
| Correspondent | John E Sawyer WELCH ALLYN, INC. 4341 STATE ST. RD. Skaneateles Falls, NY 13153 -0220 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-09 |
| Decision Date | 2005-12-16 |
| Summary: | summary |