510(k) K902460
K902460 is an FDA 510(k) premarket notification submitted by Oakfield Instruments, Ltd. for the device "CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)". The FDA issued a decision of Substantially Equivalent on August 28, 1990. The device falls under product code IZD (Probe, Uptake, Nuclear), a Class I device regulated under 21 CFR 892.1320. Oakfield Instruments, Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1990
- Date Received
- June 4, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Uptake, Nuclear
- Device Class
- Class I
- Regulation Number
- 892.1320
- Review Panel
- RA
- Submission Type