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FDA 510(k)

MDX 2000, DIGITAL ANALYZER

K-Number: K970824 · 1997-05-30

ApplicantShotwell & Carr, Inc.
Decision Date1997-05-30
Product CodeJOY
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MDX 2000, DIGITAL ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Shotwell & Carr, Inc.. It received FDA 510(k) clearance on 1997-05-30 under 510(k) number K970824. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MDX 2000, DIGITAL ANALYZER?

MDX 2000, DIGITAL ANALYZER is a medical device that received FDA 510(k) clearance on 1997-05-30. The listed applicant is Shotwell & Carr, Inc.. The 510(k) number is K970824.

When did MDX 2000, DIGITAL ANALYZER receive FDA 510(k) clearance?

MDX 2000, DIGITAL ANALYZER received FDA 510(k) clearance on 1997-05-30, under 510(k) number K970824.

Who is the listed applicant for MDX 2000, DIGITAL ANALYZER?

The FDA 510(k) record lists Shotwell & Carr, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MDX 2000, DIGITAL ANALYZER?

The FDA product code for MDX 2000, DIGITAL ANALYZER is JOY.

Related Clinical Trials

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Other records listing Shotwell & Carr, 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.

K961011DTX-200 BONE DENSITOMETERK950617SMART WAVE GS100

Related Devices (Code: JOY)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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