FDA 510(k)

ERGO SRS

K-Number: K031281 · 2003-12-23

Decision Date2003-12-23

Product CodeMUJ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ERGO SRS 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 2003-12-23 under 510(k) number K031281. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGO SRS?

ERGO SRS is a medical device that received FDA 510(k) clearance on 2003-12-23. The listed applicant is 3D Line USA, Inc.. The 510(k) number is K031281.

When did ERGO SRS receive FDA 510(k) clearance?

ERGO SRS received FDA 510(k) clearance on 2003-12-23, under 510(k) number K031281.

Who is the listed applicant for ERGO SRS?

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 ERGO SRS?

The FDA product code for ERGO SRS is MUJ.

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.

K034051DYNATRAC, COD. 50-1A K031631STEREOTACTIC BODY FRAME, MODEL COD. 70-1A K013535EVTOOL MODEL # V. 1.0 K0112553D LINE STEROTACTIC HARDWARE ACCESSORIES K001163DMLC IV-ERGO

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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.