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FDA 510(k)

MARTIN TRACH-SECURE

K-Number: K801931 · 1980-08-27

ApplicantAcucare Medical, Inc.
Decision Date1980-08-27
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MARTIN TRACH-SECURE is the device name listed in this FDA 510(k) record. The listed applicant is Acucare Medical, Inc.. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801931. 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 MARTIN TRACH-SECURE?

MARTIN TRACH-SECURE is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Acucare Medical, Inc.. The 510(k) number is K801931.

When did MARTIN TRACH-SECURE receive FDA 510(k) clearance?

MARTIN TRACH-SECURE received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801931.

Who is the listed applicant for MARTIN TRACH-SECURE?

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

What is the FDA product code for MARTIN TRACH-SECURE?

The FDA product code for MARTIN TRACH-SECURE is BTO.

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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

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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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