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FDA 510(k)

BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90

K-Number: K040056 · 2004-04-09

ApplicantBio-Detek, Inc.
Decision Date2004-04-09
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Detek, Inc.. It received FDA 510(k) clearance on 2004-04-09 under 510(k) number K040056. 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 BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90?

BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 is a medical device that received FDA 510(k) clearance on 2004-04-09. The listed applicant is Bio-Detek, Inc.. The 510(k) number is K040056.

When did BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 receive FDA 510(k) clearance?

BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 received FDA 510(k) clearance on 2004-04-09, under 510(k) number K040056.

Who is the listed applicant for BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90?

The FDA 510(k) record lists Bio-Detek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90?

The FDA product code for BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90 is MKJ. This falls under the Dental category.

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Other records listing Bio-Detek, Inc. as applicant

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Related Devices (Code: MKJ)

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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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