FDA 510(k)

SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT

K-Number: K945407 · 1995-02-27

Decision Date1995-02-27

Product CodeBTO

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Medical Tpi, Inc.. It received FDA 510(k) clearance on 1995-02-27 under 510(k) number K945407. 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 SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT?

SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Mallinckrodt Medical Tpi, Inc.. The 510(k) number is K945407.

When did SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT receive FDA 510(k) clearance?

SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT received FDA 510(k) clearance on 1995-02-27, under 510(k) number K945407.

Who is the listed applicant for SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT?

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

What is the FDA product code for SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT?

The FDA product code for SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT is BTO.

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Other records listing Mallinckrodt Medical Tpi, Inc. as applicant

K945406SSV PHONATE(TM) SHILEY SPEAKING VALVE K936224REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS K930895SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

Related Devices (Code: BTO)

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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.