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FDA 510(k)

Patient Monitor

K-Number: K160981 · 2016-12-22

ApplicantEdan Instruments, Inc.
Decision Date2016-12-22
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor 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 2016-12-22 under 510(k) number K160981. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Patient Monitor?

Patient Monitor is a medical device that received FDA 510(k) clearance on 2016-12-22. The listed applicant is Edan Instruments, Inc.. The 510(k) number is K160981.

When did Patient Monitor receive FDA 510(k) clearance?

Patient Monitor received FDA 510(k) clearance on 2016-12-22, under 510(k) number K160981.

Who is the listed applicant for Patient Monitor?

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 Patient Monitor?

The FDA product code for Patient Monitor is MHX.

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.

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)K250214Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)

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Related Devices (Code: MHX)

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.

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics 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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