Nihon Kohden Vital Sign Telemeter
FDA 510(k) K163459 · Nihon Kohden Corporation
510(k) numberK163459
Submission
- Device name
- Nihon Kohden Vital Sign Telemeter
- Applicant
- Nihon Kohden Corporation
Tokyo, JP - Received
- December 9, 2016
- Decision date
- April 4, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
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Questions and answers
When was Nihon Kohden Vital Sign Telemeter cleared by the FDA?
Nihon Kohden Vital Sign Telemeter (K163459) received a 510(k) decision of Substantially Equivalent on April 4, 2017, 116 days after the submission was received.
What is the product code of K163459?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.