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FDA 510(k)

PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20

K-Number: K040479 · 2004-09-14

ApplicantWelch Allyn, Inc.
Decision Date2004-09-14
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 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 2004-09-14 under 510(k) number K040479. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20?

PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 is a medical device that received FDA 510(k) clearance on 2004-09-14. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K040479.

When did PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 receive FDA 510(k) clearance?

PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 received FDA 510(k) clearance on 2004-09-14, under 510(k) number K040479.

Who is the listed applicant for PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20?

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 PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20?

The FDA product code for PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 is MKJ. This falls under the Dental category.

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Other records listing Welch Allyn, Inc. as applicant

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Related Devices (Code: MKJ)

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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