510(k) K022069
K022069 is an FDA 510(k) premarket notification submitted by Ge Oec Medical Systems for the device "OEC FLUOROTRAK 9800 PLUS". The FDA issued a decision of Substantially Equivalent on September 17, 2002. The device falls under product code OWB (Interventional Fluoroscopic X-Ray System), a Class II device regulated under 21 CFR 892.1650. Ge Oec Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2002
- Date Received
- June 25, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interventional Fluoroscopic X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type
Interventional fluoroscopy