510(k) K001112
K001112 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "GE MARQUETTE CLINICAL INFORMATION CENTER, GE MARQUETTE CIC". The FDA issued a decision of Substantially Equivalent on June 14, 2000. The device falls under product code DXJ (Display, Cathode-Ray Tube, Medical), a Class II device regulated under 21 CFR 870.2450. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2000
- Date Received
- April 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Cathode-Ray Tube, Medical
- Device Class
- Class II
- Regulation Number
- 870.2450
- Review Panel
- CV
- Submission Type