Nihon Kohden CO2 Monitor— 510(k) K171765
Substantially EquivalentNihon Kohden Corporation
FDA 510(k) clearance K171765 for Nihon Kohden CO2 Monitor, Substantially Equivalent on 2017-10-11. Applicant: Nihon Kohden Corporation. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden Corporation
- Product code
- Code CCK
- Device class
- Class 2
- Regulation
- 21 CFR 868.1400
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code CCK
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- K223567 — CNS-2101 Central Monitor
- K220976 — Life Scope PT BSM-1700 Series Bedside Monitor
- K213316 — Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
Adverse events under product code CCK
product code CCK- Death
- 3
- Malfunction
- 11,428
- Total
- 11,431
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K171765
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171765.
Data sourced from openFDA. This site is unofficial and independent of the FDA.