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FDA 510(k)

WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE

K-Number: K040490 · 2004-08-18

ApplicantWelch Allyn, Inc.
Decision Date2004-08-18
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE 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 2004-08-18 under 510(k) number K040490. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE?

WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE is a medical device that received FDA 510(k) clearance on 2004-08-18. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K040490.

When did WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE receive FDA 510(k) clearance?

WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE received FDA 510(k) clearance on 2004-08-18, under 510(k) number K040490.

Who is the listed applicant for WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE?

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 SPOT ULTRA VITAL SIGNS DEVICE?

The FDA product code for WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE is DXN.

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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: DXN)

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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