Submission Details
| 510(k) Number | K040395 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 17, 2004 |
| Decision Date | June 01, 2004 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES
Jun 2004
Decision
105d
Days
Class 2
Risk
About This 510(k) Submission
K040395 is an FDA 510(k) clearance for the CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Nihon Kohden America, Inc. (Foothill Ranch, US). The FDA issued a Cleared decision on June 1, 2004, 105 days after receiving the submission on February 17, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.
Device Classification
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1025 |
Manufacturer
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