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FDA 510(k)

Surveyor S4 Mobile Monitor

K-Number: K160685 · 2016-08-04

ApplicantMortara Instrument, Inc.
Decision Date2016-08-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surveyor S4 Mobile Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K160685. 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 Surveyor S4 Mobile Monitor?

Surveyor S4 Mobile Monitor is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K160685.

When did Surveyor S4 Mobile Monitor receive FDA 510(k) clearance?

Surveyor S4 Mobile Monitor received FDA 510(k) clearance on 2016-08-04, under 510(k) number K160685.

Who is the listed applicant for Surveyor S4 Mobile Monitor?

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

What is the FDA product code for Surveyor S4 Mobile Monitor?

The FDA product code for Surveyor S4 Mobile Monitor is MHX.

Other records listing Mortara Instrument, 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.

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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.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.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.

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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