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FDA 510(k)

WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM

K-Number: K981937 · 1998-08-24

ApplicantWelch Allyn, Inc.
Decision Date1998-08-24
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM 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 1998-08-24 under 510(k) number K981937. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM?

WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-24. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K981937.

When did WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM receive FDA 510(k) clearance?

WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM received FDA 510(k) clearance on 1998-08-24, under 510(k) number K981937.

Who is the listed applicant for WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM?

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 REVEAL INTRAORAL CAMERA SYSTEM?

The FDA product code for WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM is EIA.

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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: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, LLC

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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