The following data is part of a premarket notification filed by Oakfield Instruments, Ltd. with the FDA for Cardioscint (left Ventricular Function Monitor).
| Device ID | K902460 |
| 510k Number | K902460 |
| Device Name: | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) |
| Classification | Probe, Uptake, Nuclear |
| Applicant | OAKFIELD INSTRUMENTS, LTD. OAKFIELD INDUSTRIAL ESTATE STANTON HARCOURT RD, EYNSHAM Oxon Ox8 1ja England, GB |
| Contact | John Giddings |
| Correspondent | John Giddings OAKFIELD INSTRUMENTS, LTD. OAKFIELD INDUSTRIAL ESTATE STANTON HARCOURT RD, EYNSHAM Oxon Ox8 1ja England, GB |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-08-28 |