K831818 is an FDA 510(k) clearance for the CENTRAL STATION MONITOR CSM-100. This device is classified as a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT).
Submitted by Honeywell, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983, 147 days after receiving the submission on June 6, 1983.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K831818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 1983 |
| Decision Date | October 31, 1983 |
| Days to Decision | 147 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 |