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FDA 510(k)

BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01

K-Number: K023245 · 2002-10-21

ApplicantParadigm Medical Industries, Inc.
Decision Date2002-10-21
Product CodeNJJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 is the device name listed in this FDA 510(k) record. The listed applicant is Paradigm Medical Industries, Inc.. It received FDA 510(k) clearance on 2002-10-21 under 510(k) number K023245. The device is classified under product code NJJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01?

BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 is a medical device that received FDA 510(k) clearance on 2002-10-21. The listed applicant is Paradigm Medical Industries, Inc.. The 510(k) number is K023245.

When did BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 receive FDA 510(k) clearance?

BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 received FDA 510(k) clearance on 2002-10-21, under 510(k) number K023245.

Who is the listed applicant for BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01?

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

What is the FDA product code for BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01?

The FDA product code for BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 is NJJ.

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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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