K823904 is an FDA 510(k) clearance for the MODEL 515 NEO-TRAK NEONATAL MONITOR. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II - Special Controls, product code DRT).
Submitted by Ge Medical Systems Information Technologies (Walker, US). The FDA issued a Cleared decision on May 25, 1983, 148 days after receiving the submission on December 28, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K823904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 1982 |
| Decision Date | May 25, 1983 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DRT - Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |