K941762 is an FDA 510(k) clearance for the INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS). This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on February 22, 1995, 317 days after receiving the submission on April 11, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K941762 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 1994 |
| Decision Date | February 22, 1995 |
| Days to Decision | 317 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQK — Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |