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FDA 510(k)

DYNATRAC, COD. 50-1A

K-Number: K034051 · 2004-04-05

Applicant3D Line USA, Inc.
Decision Date2004-04-05
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DYNATRAC, COD. 50-1A is the device name listed in this FDA 510(k) record. The listed applicant is 3D Line USA, Inc.. It received FDA 510(k) clearance on 2004-04-05 under 510(k) number K034051. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNATRAC, COD. 50-1A?

DYNATRAC, COD. 50-1A is a medical device that received FDA 510(k) clearance on 2004-04-05. The listed applicant is 3D Line USA, Inc.. The 510(k) number is K034051.

When did DYNATRAC, COD. 50-1A receive FDA 510(k) clearance?

DYNATRAC, COD. 50-1A received FDA 510(k) clearance on 2004-04-05, under 510(k) number K034051.

Who is the listed applicant for DYNATRAC, COD. 50-1A?

The FDA 510(k) record lists 3D Line USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNATRAC, COD. 50-1A?

The FDA product code for DYNATRAC, COD. 50-1A is IYE.

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Other records listing 3D Line USA, 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.

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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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