The following data is part of a premarket notification filed by Protocol Systems, Inc. with the FDA for Model 100 Central Station.
| Device ID | K913193 |
| 510k Number | K913193 |
| Device Name: | MODEL 100 CENTRAL STATION |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Contact | James W Sandbert |
| Correspondent | James W Sandbert PROTOCOL SYSTEMS, INC. 8500 S.W. CREEKSIDE PLACE Beaverton, OR 97008 -7101 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-18 |
| Decision Date | 1991-10-16 |