K820416 is an FDA 510(k) clearance for the #505 PORT. VITAL FUNCTIONS NEONATAL MON. 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 March 4, 1982, 16 days after receiving the submission on February 16, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K820416 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1982 |
| Decision Date | March 04, 1982 |
| Days to Decision | 16 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 |