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FDA 510(k)

PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM

K-Number: K903699 · 1990-09-04

ApplicantPassy & Passy, Inc.
Decision Date1990-09-04
Product CodeJOH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM is the device name listed in this FDA 510(k) record. The listed applicant is Passy & Passy, Inc.. It received FDA 510(k) clearance on 1990-09-04 under 510(k) number K903699. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM?

PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM is a medical device that received FDA 510(k) clearance on 1990-09-04. The listed applicant is Passy & Passy, Inc.. The 510(k) number is K903699.

When did PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM receive FDA 510(k) clearance?

PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM received FDA 510(k) clearance on 1990-09-04, under 510(k) number K903699.

Who is the listed applicant for PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM?

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

What is the FDA product code for PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM?

The FDA product code for PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM is JOH.

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 Passy & Passy, 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.

K851016PASSY-MUIR TRACH VALVE

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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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