K861861 is an FDA 510(k) clearance for the 515A NEO-TRAK NEONATAL MONITOR. 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 (Wallingford, US). The FDA issued a Cleared decision on July 10, 1986, 57 days after receiving the submission on May 14, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2500.
| 510(k) Number | K861861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1986 |
| Decision Date | July 10, 1986 |
| Days to Decision | 57 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 |