Submission Details
| 510(k) Number | K080342 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 08, 2008 |
| Decision Date | February 26, 2008 |
| Days to Decision | 18 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES
Feb 2008
Decision
18d
Days
Class 2
Risk
About This 510(k) Submission
K080342 is an FDA 510(k) clearance for the NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S 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 February 26, 2008, 18 days after receiving the submission on February 8, 2008. 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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