The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Acuity Central Station.
| Device ID | K972121 |
| 510k Number | K972121 |
| Device Name: | ACUITY CENTRAL STATION |
| Classification | Monitor, St Segment With Alarm |
| Applicant | PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Contact | James P Welch |
| Correspondent | James P Welch PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-05 |
| Decision Date | 1997-11-07 |
| Summary: | summary |