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FDA 510(k)

WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C

K-Number: K852574 · 1986-03-13

ApplicantWelch Allyn, Inc.
Decision Date1986-03-13
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C 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 1986-03-13 under 510(k) number K852574. 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 MODEL 40000 SPHYG W/ 40030-35 BLAD & C?

WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C is a medical device that received FDA 510(k) clearance on 1986-03-13. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K852574.

When did WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C receive FDA 510(k) clearance?

WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C received FDA 510(k) clearance on 1986-03-13, under 510(k) number K852574.

Who is the listed applicant for WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C?

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 MODEL 40000 SPHYG W/ 40030-35 BLAD & C?

The FDA product code for WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C 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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