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FDA 510(k)

COMEN MULTI-PARAMETER PATIENT MONITOR

K-Number: K112877 · 2012-11-07

ApplicantGoldway (Us), Inc.
Decision Date2012-11-07
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMEN MULTI-PARAMETER PATIENT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Goldway (Us), Inc.. It received FDA 510(k) clearance on 2012-11-07 under 510(k) number K112877. 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 COMEN MULTI-PARAMETER PATIENT MONITOR?

COMEN MULTI-PARAMETER PATIENT MONITOR is a medical device that received FDA 510(k) clearance on 2012-11-07. The listed applicant is Goldway (Us), Inc.. The 510(k) number is K112877.

When did COMEN MULTI-PARAMETER PATIENT MONITOR receive FDA 510(k) clearance?

COMEN MULTI-PARAMETER PATIENT MONITOR received FDA 510(k) clearance on 2012-11-07, under 510(k) number K112877.

Who is the listed applicant for COMEN MULTI-PARAMETER PATIENT MONITOR?

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

What is the FDA product code for COMEN MULTI-PARAMETER PATIENT MONITOR?

The FDA product code for COMEN MULTI-PARAMETER PATIENT MONITOR 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.

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Other records listing Goldway (Us), 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.

K033988GOLDWAY UT4000A VITAL SIGNS MONITORK021154GOLDWAY PATIENT MONITOR, MODEL # UT4000FK021153GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000

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.

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