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— 510(k) K213316
Substantially EquivalentNihon Kohden Corporation
FDA 510(k) clearance K213316 for 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, Substantially Equivalent on 2021-12-29. Applicant: Nihon Kohden Corporation. Device class: 2.
Clearance details
- Applicant
- Nihon Kohden Corporation
- Product code
- Code KOI
- Device class
- Class 2
- Regulation
- 21 CFR 868.2775
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Tokyo, JP
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Data sourced from openFDA. This site is unofficial and independent of the FDA.