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FDA 510(k)

OTOSCOPE, DIAG. MODELS 20100 & 20200

K-Number: K781029 · 1978-06-28

ApplicantWelch Allyn, Inc.
Decision Date1978-06-28
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOSCOPE, DIAG. MODELS 20100 & 20200 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 1978-06-28 under 510(k) number K781029. The device is classified under product code ERA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOSCOPE, DIAG. MODELS 20100 & 20200?

OTOSCOPE, DIAG. MODELS 20100 & 20200 is a medical device that received FDA 510(k) clearance on 1978-06-28. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K781029.

When did OTOSCOPE, DIAG. MODELS 20100 & 20200 receive FDA 510(k) clearance?

OTOSCOPE, DIAG. MODELS 20100 & 20200 received FDA 510(k) clearance on 1978-06-28, under 510(k) number K781029.

Who is the listed applicant for OTOSCOPE, DIAG. MODELS 20100 & 20200?

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 OTOSCOPE, DIAG. MODELS 20100 & 20200?

The FDA product code for OTOSCOPE, DIAG. MODELS 20100 & 20200 is ERA.

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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: ERA)

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.

K123821AIO HD OTOSCOPEBlue FocusK121326LANTOS 3D EAR SCANNERLantos TechnologiesK110326OSRAM ITOSOsram Sylvania, Inc.K945264OPTUS OTOSCOPESOptus, Inc.K955043WELCH ALLYN BI-OTOSCOPEWelch Allyn, Inc.K952578WELCH ALLY OTOSCOPEWelch Allyn, 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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