The following data is part of a premarket notification filed by Medac, Inc. with the FDA for Monitor, Electrographic.
| Device ID | K874319 |
| 510k Number | K874319 |
| Device Name: | MONITOR, ELECTROGRAPHIC |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | MEDAC, INC. 25115 SW PARKWAY AVE. Wilsonville, OR 97070 |
| Contact | Robert M Boonstra |
| Correspondent | Robert M Boonstra MEDAC, INC. 25115 SW PARKWAY AVE. Wilsonville, OR 97070 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-21 |
| Decision Date | 1988-03-07 |