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FDA 510(k)

FITTRONIC

K-Number: K861796 · 1986-06-25

ApplicantCorleone Intl. Traders, Inc.
Decision Date1986-06-25
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FITTRONIC is the device name listed in this FDA 510(k) record. The listed applicant is Corleone Intl. Traders, Inc.. It received FDA 510(k) clearance on 1986-06-25 under 510(k) number K861796. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FITTRONIC?

FITTRONIC is a medical device that received FDA 510(k) clearance on 1986-06-25. The listed applicant is Corleone Intl. Traders, Inc.. The 510(k) number is K861796.

When did FITTRONIC receive FDA 510(k) clearance?

FITTRONIC received FDA 510(k) clearance on 1986-06-25, under 510(k) number K861796.

Who is the listed applicant for FITTRONIC?

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

What is the FDA product code for FITTRONIC?

The FDA product code for FITTRONIC is IPF.

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Related Devices (Code: IPF)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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