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FDA 510(k)

WELCH ALLYN EARCLEANER

K-Number: K931946 · 1993-07-26

ApplicantWelch Allyn, Inc.
Decision Date1993-07-26
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN EARCLEANER 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 1993-07-26 under 510(k) number K931946. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCH ALLYN EARCLEANER?

WELCH ALLYN EARCLEANER is a medical device that received FDA 510(k) clearance on 1993-07-26. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K931946.

When did WELCH ALLYN EARCLEANER receive FDA 510(k) clearance?

WELCH ALLYN EARCLEANER received FDA 510(k) clearance on 1993-07-26, under 510(k) number K931946.

Who is the listed applicant for WELCH ALLYN EARCLEANER?

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 EARCLEANER?

The FDA product code for WELCH ALLYN EARCLEANER is KYZ.

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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: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, Inc.

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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