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FDA 510(k)

NOVATRANS II

K-Number: K951129 · 1995-04-05

ApplicantMedex, Inc.
Decision Date1995-04-05
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVATRANS II is the device name listed in this FDA 510(k) record. The listed applicant is Medex, Inc.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K951129. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVATRANS II?

NOVATRANS II is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is Medex, Inc.. The 510(k) number is K951129.

When did NOVATRANS II receive FDA 510(k) clearance?

NOVATRANS II received FDA 510(k) clearance on 1995-04-05, under 510(k) number K951129.

Who is the listed applicant for NOVATRANS II?

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

What is the FDA product code for NOVATRANS II?

The FDA product code for NOVATRANS II is DRS.

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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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