FDA 510(k)

FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES

K-Number: K862267 · 1986-06-18

Decision Date1986-06-18

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1986-06-18 under 510(k) number K862267. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES?

FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES is a medical device that received FDA 510(k) clearance on 1986-06-18. The listed applicant is Bivona Medical Technologies. The 510(k) number is K862267.

When did FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES receive FDA 510(k) clearance?

FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES received FDA 510(k) clearance on 1986-06-18, under 510(k) number K862267.

Who is the listed applicant for FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES?

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

What is the FDA product code for FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES?

The FDA product code for FOME-CUF AND AIRE CUF TRACHEOSTOMY TUBES is BTO.

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Other records listing Bivona Medical Technologies as applicant

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Related Devices (Code: BTO)

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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.