510(k) K020524
K020524 is an FDA 510(k) premarket notification submitted by General Electric Medical Systems Information Techn for the device "PATIENTNET MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 20, 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
- March 20, 2002
- Date Received
- February 19, 2002
- Clearance Type
- Special
- 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