510(k) K832652
K832652 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "OXY MONITOR 5-RANGE DUAL-THERMISTOR". The FDA issued a decision of Substantially Equivalent on Dec 22, 1983. 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. Litton Medical Electronics has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 1983
- Date Received
- Aug 8, 1983
- 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
- 510(k) Exempt