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FDA 510(k)

GOLDWAY PATIENT MONITOR, MODEL # UT4000F

K-Number: K021154 · 2003-04-11

ApplicantGoldway Us, Inc.
Decision Date2003-04-11
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

GOLDWAY PATIENT MONITOR, MODEL # UT4000F 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 2003-04-11 under 510(k) number K021154. 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 GOLDWAY PATIENT MONITOR, MODEL # UT4000F?

GOLDWAY PATIENT MONITOR, MODEL # UT4000F is a medical device that received FDA 510(k) clearance on 2003-04-11. The listed applicant is Goldway Us, Inc.. The 510(k) number is K021154.

When did GOLDWAY PATIENT MONITOR, MODEL # UT4000F receive FDA 510(k) clearance?

GOLDWAY PATIENT MONITOR, MODEL # UT4000F received FDA 510(k) clearance on 2003-04-11, under 510(k) number K021154.

Who is the listed applicant for GOLDWAY PATIENT MONITOR, MODEL # UT4000F?

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 GOLDWAY PATIENT MONITOR, MODEL # UT4000F?

The FDA product code for GOLDWAY PATIENT MONITOR, MODEL # UT4000F 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.

K112877COMEN MULTI-PARAMETER PATIENT MONITORK033988GOLDWAY UT4000A VITAL SIGNS MONITORK021153GOLDWAY 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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