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FDA 510(k)

OMNI-TRAC MODIFICATION

K-Number: K935020 · 1995-04-26

ApplicantInvivo Research, Inc.
Decision Date1995-04-26
Product CodeMLD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OMNI-TRAC MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Research, Inc.. It received FDA 510(k) clearance on 1995-04-26 under 510(k) number K935020. The device is classified under product code MLD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNI-TRAC MODIFICATION?

OMNI-TRAC MODIFICATION is a medical device that received FDA 510(k) clearance on 1995-04-26. The listed applicant is Invivo Research, Inc.. The 510(k) number is K935020.

When did OMNI-TRAC MODIFICATION receive FDA 510(k) clearance?

OMNI-TRAC MODIFICATION received FDA 510(k) clearance on 1995-04-26, under 510(k) number K935020.

Who is the listed applicant for OMNI-TRAC MODIFICATION?

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

What is the FDA product code for OMNI-TRAC MODIFICATION?

The FDA product code for OMNI-TRAC MODIFICATION is MLD.

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Other records listing Invivo Research, Inc. as applicant

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Related Devices (Code: MLD)

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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