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FDA 510(k)

FOCUS T41,T41F,T43, T43F,T44F

K-Number: K904255 · 1991-01-18

ApplicantElamedical
Decision Date1991-01-18
Product CodeDTB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOCUS T41,T41F,T43, T43F,T44F is the device name listed in this FDA 510(k) record. The listed applicant is Elamedical. It received FDA 510(k) clearance on 1991-01-18 under 510(k) number K904255. The device is classified under product code DTB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOCUS T41,T41F,T43, T43F,T44F?

FOCUS T41,T41F,T43, T43F,T44F is a medical device that received FDA 510(k) clearance on 1991-01-18. The listed applicant is Elamedical. The 510(k) number is K904255.

When did FOCUS T41,T41F,T43, T43F,T44F receive FDA 510(k) clearance?

FOCUS T41,T41F,T43, T43F,T44F received FDA 510(k) clearance on 1991-01-18, under 510(k) number K904255.

Who is the listed applicant for FOCUS T41,T41F,T43, T43F,T44F?

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

What is the FDA product code for FOCUS T41,T41F,T43, T43F,T44F?

The FDA product code for FOCUS T41,T41F,T43, T43F,T44F is DTB.

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Related Devices (Code: DTB)

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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