K033957 is an FDA 510(k) clearance for the INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Draeger Medical Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on May 14, 2004, 144 days after receiving the submission on December 22, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K033957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2003 |
| Decision Date | May 14, 2004 |
| Days to Decision | 144 days |
| Submission Type | Special |
| 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 |