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FDA 510(k)

VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)

K-Number: K053027 · 2005-11-22

ApplicantWelch Allyn, Inc.
Decision Date2005-11-22
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2005-11-22 under 510(k) number K053027. 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 VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)?

VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) is a medical device that received FDA 510(k) clearance on 2005-11-22. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K053027.

When did VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) receive FDA 510(k) clearance?

VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) received FDA 510(k) clearance on 2005-11-22, under 510(k) number K053027.

Who is the listed applicant for VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)?

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

What is the FDA product code for VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)?

The FDA product code for VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) is MWI.

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Other records listing Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

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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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