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FDA 510(k)

WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE

K-Number: K053381 · 2006-06-15

ApplicantWelch Allyn, Inc.
Decision Date2006-06-15
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE 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 2006-06-15 under 510(k) number K053381. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE?

WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE is a medical device that received FDA 510(k) clearance on 2006-06-15. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K053381.

When did WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE receive FDA 510(k) clearance?

WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE received FDA 510(k) clearance on 2006-06-15, under 510(k) number K053381.

Who is the listed applicant for WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE?

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 WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE?

The FDA product code for WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE is DQA.

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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: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply 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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