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FDA 510(k)

FLOSENSE II, MODEL 29-8040

K-Number: K033939 · 2004-01-30

ApplicantSdi Diagnostics, Inc.
Decision Date2004-01-30
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOSENSE II, MODEL 29-8040 is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-01-30 under 510(k) number K033939. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOSENSE II, MODEL 29-8040?

FLOSENSE II, MODEL 29-8040 is a medical device that received FDA 510(k) clearance on 2004-01-30. The listed applicant is Sdi Diagnostics, Inc.. The 510(k) number is K033939.

When did FLOSENSE II, MODEL 29-8040 receive FDA 510(k) clearance?

FLOSENSE II, MODEL 29-8040 received FDA 510(k) clearance on 2004-01-30, under 510(k) number K033939.

Who is the listed applicant for FLOSENSE II, MODEL 29-8040?

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

What is the FDA product code for FLOSENSE II, MODEL 29-8040?

The FDA product code for FLOSENSE II, MODEL 29-8040 is BZG.

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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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