The following data is part of a premarket notification filed by Futurecare Systems, Inc. with the FDA for Futurecare Carelynk Iv System.
| Device ID | K903512 |
| 510k Number | K903512 |
| Device Name: | FUTURECARE CARELYNK IV SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | FUTURECARE SYSTEMS, INC. 4364 ROUND LAKE ROAD, WEST St. Paul, MN 55112 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-03 |
| Decision Date | 1991-07-18 |