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FDA 510(k)

WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE

K-Number: K052158 · 2005-09-08

ApplicantWelch Allyn, Inc.
Decision Date2005-09-08
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 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 2005-09-08 under 510(k) number K052158. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE?

WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE is a medical device that received FDA 510(k) clearance on 2005-09-08. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K052158.

When did WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE receive FDA 510(k) clearance?

WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE received FDA 510(k) clearance on 2005-09-08, under 510(k) number K052158.

Who is the listed applicant for WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 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 CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE?

The FDA product code for WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE is BZG.

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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: BZG)

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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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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