The following data is part of a premarket notification filed by Scottcare Corp. with the FDA for Telerehab System For Cardiac Rehabilitation.
| Device ID | K895719 |
| 510k Number | K895719 |
| Device Name: | TELEREHAB SYSTEM FOR CARDIAC REHABILITATION |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | SCOTTCARE CORP. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale SCOTTCARE CORP. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-25 |
| Decision Date | 1990-03-06 |