Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s

K-Number: K202892 · 2021-01-28

ApplicantEdan Instruments, Inc.
Decision Date2021-01-28
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s is the device name listed in this FDA 510(k) record. The listed applicant is Edan Instruments, Inc.. It received FDA 510(k) clearance on 2021-01-28 under 510(k) number K202892. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s?

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s is a medical device that received FDA 510(k) clearance on 2021-01-28. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K202892.

When did Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s receive FDA 510(k) clearance?

Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s received FDA 510(k) clearance on 2021-01-28, under 510(k) number K202892.

Who is the listed applicant for Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s?

The FDA 510(k) record lists Edan Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s?

The FDA product code for Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s is MWI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04011163Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical PainACTIVE_NOT_RECRUITINGNCT06238180Personalised Real-time Interoperable Sepsis Monitoring (PRISM)WITHDRAWNNCT06693817Advanced Wireless Sensors for Neonatal Care in the Delivery RoomRECRUITINGNCT06942338Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.NOT_YET_RECRUITINGNCT07231653Home Monitoring Study for Surgical PatientsNOT_YET_RECRUITINGNCT07496346Integration of a Robotic Platform for Clinical Monitoring of Patients With Severe Acquired Brain Injury in High-Intensity Care UnitsNOT_YET_RECRUITING

Other records listing Edan Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)K251591Holter ECG and ABP system (HolterABP)K251268Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)K241882Fetal & Maternal Monitor (F15A, F15A Air)K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

View all 50 devices →

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑