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FDA 510(k)

TRACHEOSTOMY CARE KIT

K-Number: K941470 · 1995-02-14

ApplicantClinical Resources, Inc.
Decision Date1995-02-14
Product CodeBTO
Advisory CommitteeAN
DecisionUnknown

Device Summary

TRACHEOSTOMY CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Resources, Inc.. It received FDA 510(k) clearance on 1995-02-14 under 510(k) number K941470. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the TRACHEOSTOMY CARE KIT?

TRACHEOSTOMY CARE KIT is a medical device that received FDA 510(k) clearance on 1995-02-14. The listed applicant is Clinical Resources, Inc.. The 510(k) number is K941470.

When did TRACHEOSTOMY CARE KIT receive FDA 510(k) clearance?

TRACHEOSTOMY CARE KIT received FDA 510(k) clearance on 1995-02-14, under 510(k) number K941470.

Who is the listed applicant for TRACHEOSTOMY CARE KIT?

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

What is the FDA product code for TRACHEOSTOMY CARE KIT?

The FDA product code for TRACHEOSTOMY CARE KIT is BTO.

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Other records listing Clinical Resources, 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.

K944882IRRIGATION TRAYK944881SKIN SCRUB TRAYK945020FLUFF GAUZE SPONGEK945021FLUFF GAUZE SPONGEK945019FLUFF GAUXZE ROLLK944879GAUZE SPONGES

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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

View on FDA Database →

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

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