K823210 is an FDA 510(k) clearance for the MODEL 525 NEO-TRAK NEONATAL RECORDER. This device is classified as a Recorder, Paper Chart (Class I - General Controls, product code DSF).
Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on November 24, 1982, 27 days after receiving the submission on October 28, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2810.
| 510(k) Number | K823210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1982 |
| Decision Date | November 24, 1982 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DSF - Recorder, Paper Chart |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2810 |