Prefense EDNS-9000 Series Nurse Central Station
FDA 510(k) K073550 · Nihon Kohden America, Inc.
510(k) numberK073550
Submission
- Device name
- Prefense EDNS-9000 Series Nurse Central Station
- Applicant
- Nihon Kohden America, Inc.
Foothill, CA, US - Received
- December 18, 2007
- Decision date
- March 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
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| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
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| K080546 | Nihon Kohden EEG-1200A Series Neurofax, Model EEG-1200AOLT · Special | 08/29/2008SE |
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Questions and answers
When was Prefense EDNS-9000 Series Nurse Central Station cleared by the FDA?
Prefense EDNS-9000 Series Nurse Central Station (K073550) received a 510(k) decision of Substantially Equivalent on March 28, 2008, 101 days after the submission was received.
What is the product code of K073550?
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.