510(k) K020661
K020661 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "UNITY IS PATIENT VIEWER". The FDA issued a decision of Substantially Equivalent on May 24, 2002. The device falls under product code MSX (System, Network And Communication, Physiological Monitors), a Class II device regulated under 21 CFR 870.2300. General Electric Medical Systems Information Techn has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2002
- Date Received
- March 1, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Network And Communication, Physiological Monitors
- Device Class
- Class II
- Regulation Number
- 870.2300
- Review Panel
- CV
- Submission Type