K033738 is an FDA 510(k) clearance for the MONITORING SYSTEM, MODEL ARGUS PB-2200. This device is classified as a Computer, Blood-pressure (Class II - Special Controls, product code DSK).
Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on August 24, 2004, 270 days after receiving the submission on November 28, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1110.
| 510(k) Number | K033738 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 2003 |
| Decision Date | August 24, 2004 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSK - Computer, Blood-pressure |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1110 |