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FDA 510(k)

STETHOFLUX

K-Number: K060064 · 2006-04-10

ApplicantOdvi
Decision Date2006-04-10
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STETHOFLUX is the device name listed in this FDA 510(k) record. The listed applicant is Odvi. It received FDA 510(k) clearance on 2006-04-10 under 510(k) number K060064. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STETHOFLUX?

STETHOFLUX is a medical device that received FDA 510(k) clearance on 2006-04-10. The listed applicant is Odvi. The 510(k) number is K060064.

When did STETHOFLUX receive FDA 510(k) clearance?

STETHOFLUX received FDA 510(k) clearance on 2006-04-10, under 510(k) number K060064.

Who is the listed applicant for STETHOFLUX?

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

What is the FDA product code for STETHOFLUX?

The FDA product code for STETHOFLUX is JAF.

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Related Devices (Code: JAF)

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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