The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Acuity Central Monitoring Station Or Acuity Central Monitoring System, Mobile Acuity Lt, Mobile Acuity, Mobile Lt.
| Device ID | K120774 |
| 510k Number | K120774 |
| Device Name: | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Kevin Crossen |
| Correspondent | Kevin Crossen WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-14 |
| Decision Date | 2012-04-10 |
| Summary: | summary |