The following data is part of a premarket notification filed by Litton Medical Electronics with the FDA for Oxy Monitor 5-range Dual-thermistor.
| Device ID | K832652 |
| 510k Number | K832652 |
| Device Name: | OXY MONITOR 5-RANGE DUAL-THERMISTOR |
| Classification | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Applicant | LITTON MEDICAL ELECTRONICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KLK |
| CFR Regulation Number | 868.2500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-08 |
| Decision Date | 1983-12-22 |