The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Cardiac Performance Monitor.
| Device ID | K864583 |
| 510k Number | K864583 |
| Device Name: | CARDIAC PERFORMANCE MONITOR |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED MEDICAL DEVICE CONSULTANTS,INC 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Contact | James R Veale |
| Correspondent | James R Veale VASCULAR TECHNOLOGY INCORPORATED MEDICAL DEVICE CONSULTANTS,INC 45 WEST STREET, SUITE 2 Attleboro, MA 02703 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-20 |
| Decision Date | 1987-05-11 |