510(k) K810873
K810873 is an FDA 510(k) premarket notification submitted by Intl. General Electric Co. for the device "STAR". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code JWM (System, Tomographic, Nuclear), a Class II device regulated under 21 CFR 892.1310.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1981
- Date Received
- March 31, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomographic, Nuclear
- Device Class
- Class II
- Regulation Number
- 892.1310
- Review Panel
- RA
- Submission Type