K844353 is an FDA 510(k) clearance for the PHYSIOLOGICAL MONITOR 2100. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on April 1, 1985, 143 days after receiving the submission on November 9, 1984.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K844353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1984 |
| Decision Date | April 01, 1985 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |