510(k) K861861
K861861 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Information Technologies for the device "515A NEO-TRAK NEONATAL MONITOR". The FDA issued a decision of Substantially Equivalent on July 10, 1986. The device falls under product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia), a Class II device regulated under 21 CFR 868.2500. Ge Medical Systems Information Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 1986
- Date Received
- May 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.2500
- Review Panel
- AN
- Submission Type