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FDA 510(k)

ZMACHINE, MODEL DT-100

K-Number: K101830 · 2011-03-31

ApplicantConsolidated Research of Richmond, Inc.
Decision Date2011-03-31
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ZMACHINE, MODEL DT-100 is the device name listed in this FDA 510(k) record. The listed applicant is Consolidated Research of Richmond, Inc.. It received FDA 510(k) clearance on 2011-03-31 under 510(k) number K101830. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZMACHINE, MODEL DT-100?

ZMACHINE, MODEL DT-100 is a medical device that received FDA 510(k) clearance on 2011-03-31. The listed applicant is Consolidated Research of Richmond, Inc.. The 510(k) number is K101830.

When did ZMACHINE, MODEL DT-100 receive FDA 510(k) clearance?

ZMACHINE, MODEL DT-100 received FDA 510(k) clearance on 2011-03-31, under 510(k) number K101830.

Who is the listed applicant for ZMACHINE, MODEL DT-100?

The FDA 510(k) record lists Consolidated Research of Richmond, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZMACHINE, MODEL DT-100?

The FDA product code for ZMACHINE, MODEL DT-100 is OLV.

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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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