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FDA 510(k)

DR. DEDO'S FAMILY EAR EXAMINATION KIT

K-Number: K904659 · 1991-04-30

ApplicantPanex Corp.
Decision Date1991-04-30
Product CodeERA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DR. DEDO'S FAMILY EAR EXAMINATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Panex Corp.. It received FDA 510(k) clearance on 1991-04-30 under 510(k) number K904659. 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 DR. DEDO'S FAMILY EAR EXAMINATION KIT?

DR. DEDO'S FAMILY EAR EXAMINATION KIT is a medical device that received FDA 510(k) clearance on 1991-04-30. The listed applicant is Panex Corp.. The 510(k) number is K904659.

When did DR. DEDO'S FAMILY EAR EXAMINATION KIT receive FDA 510(k) clearance?

DR. DEDO'S FAMILY EAR EXAMINATION KIT received FDA 510(k) clearance on 1991-04-30, under 510(k) number K904659.

Who is the listed applicant for DR. DEDO'S FAMILY EAR EXAMINATION KIT?

The FDA 510(k) record lists Panex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DR. DEDO'S FAMILY EAR EXAMINATION KIT?

The FDA product code for DR. DEDO'S FAMILY EAR EXAMINATION KIT is ERA.

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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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