The following data is part of a premarket notification filed by Futurecare Systems, Inc. with the FDA for Futurecare Carelynk System (entire System).
| Device ID | K871944 |
| 510k Number | K871944 |
| Device Name: | FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM) |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | FUTURECARE SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy FUTURECARE SYSTEMS, INC. 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-19 |
| Decision Date | 1987-06-24 |