K012226 is an FDA 510(k) clearance for the MONITORING SYSTEM,MODEL ARGUS PB-1000. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on April 8, 2002, 266 days after receiving the submission on July 16, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K012226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2001 |
| Decision Date | April 08, 2002 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX - Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |