Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR

K-Number: K132808 · 2013-11-20

ApplicantWelch Allyn, Inc.
Decision Date2013-11-20
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR 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 2013-11-20 under 510(k) number K132808. 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 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR?

VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K132808.

When did VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR receive FDA 510(k) clearance?

VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132808.

Who is the listed applicant for VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR?

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 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR?

The FDA product code for VITAL SIGNS MONITOR, CONNEX VITAL SIGNS 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 109 devices →

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.

↑