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FDA 510(k)

vital signs monitor

K-Number: K180380 · 2018-12-21

ApplicantEdan Instruments, Inc.
Decision Date2018-12-21
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

vital signs monitor is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2018-12-21 under approval number K180380. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the vital signs monitor?

vital signs monitor is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K180380.

When was vital signs monitor approved by the FDA?

vital signs monitor received FDA 510(k) clearance on 2018-12-21, under approval number K180380.

What company makes vital signs monitor?

vital signs monitor is manufactured by Edan Instruments, Inc..

What is the FDA product code for vital signs monitor?

The FDA product code for vital signs monitor is DQA.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40085833 The Measurement of Vital Signs in Pediatric Patients by Lifelight Software in Comparison to the Standard of Care: Protocol for the VISION-Junior Observational Study. JMIR research protocols (2025)

Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K161300Acclarix AX8 Diagnostic Ultrasound System K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System

View all 48 devices →

Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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