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FDA 510(k)

TRACH MATE

K-Number: K834265 · 1984-01-04

ApplicantTempe Biomedical, Inc.
Decision Date1984-01-04
Product CodeJAY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TRACH MATE is the device name listed in this FDA 510(k) record. The listed applicant is Tempe Biomedical, Inc.. It received FDA 510(k) clearance on 1984-01-04 under 510(k) number K834265. The device is classified under product code JAY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACH MATE?

TRACH MATE is a medical device that received FDA 510(k) clearance on 1984-01-04. The listed applicant is Tempe Biomedical, Inc.. The 510(k) number is K834265.

When did TRACH MATE receive FDA 510(k) clearance?

TRACH MATE received FDA 510(k) clearance on 1984-01-04, under 510(k) number K834265.

Who is the listed applicant for TRACH MATE?

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

What is the FDA product code for TRACH MATE?

The FDA product code for TRACH MATE is JAY.

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Related Devices (Code: JAY)

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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