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FDA 510(k)

FLOWTRON UNIVERSAL, MODEL AC600

K-Number: K010744 · 2002-03-26

ApplicantHuntleigh Healthcare, Inc.
Decision Date2002-03-26
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOWTRON UNIVERSAL, MODEL AC600 is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 2002-03-26 under 510(k) number K010744. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOWTRON UNIVERSAL, MODEL AC600?

FLOWTRON UNIVERSAL, MODEL AC600 is a medical device that received FDA 510(k) clearance on 2002-03-26. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K010744.

When did FLOWTRON UNIVERSAL, MODEL AC600 receive FDA 510(k) clearance?

FLOWTRON UNIVERSAL, MODEL AC600 received FDA 510(k) clearance on 2002-03-26, under 510(k) number K010744.

Who is the listed applicant for FLOWTRON UNIVERSAL, MODEL AC600?

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

What is the FDA product code for FLOWTRON UNIVERSAL, MODEL AC600?

The FDA product code for FLOWTRON UNIVERSAL, MODEL AC600 is JOW.

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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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