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FDA 510(k)

SSV PHONATE(TM) SHILEY SPEAKING VALVE

K-Number: K945406 · 1995-02-27

ApplicantMallinckrodt Medical Tpi, Inc.
Decision Date1995-02-27
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SSV PHONATE(TM) SHILEY SPEAKING VALVE 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 K945406. 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 SSV PHONATE(TM) SHILEY SPEAKING VALVE?

SSV PHONATE(TM) SHILEY SPEAKING VALVE 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 K945406.

When did SSV PHONATE(TM) SHILEY SPEAKING VALVE receive FDA 510(k) clearance?

SSV PHONATE(TM) SHILEY SPEAKING VALVE received FDA 510(k) clearance on 1995-02-27, under 510(k) number K945406.

Who is the listed applicant for SSV PHONATE(TM) SHILEY SPEAKING VALVE?

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 SSV PHONATE(TM) SHILEY SPEAKING VALVE?

The FDA product code for SSV PHONATE(TM) SHILEY SPEAKING VALVE is BTO.

Related Clinical Trials

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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Other records listing Mallinckrodt Medical Tpi, Inc. as applicant

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.

K945407SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORTK936224REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADSK930895SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

Related Devices (Code: BTO)

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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