K831744 is an FDA 510(k) clearance for the TRANSCUTANEOUS OXYGEN MONITOR OPTION. This device is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II - Special Controls, product code KLK).
Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on July 19, 1983, 49 days after receiving the submission on May 31, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2500.
| 510(k) Number | K831744 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 1983 |
| Decision Date | July 19, 1983 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | KLK - Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2500 |