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FDA 510(k)

EVERYTIME TRANSFUCER COVER

K-Number: K955893 · 1997-12-30

ApplicantAmedic AB
Decision Date1997-12-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVERYTIME TRANSFUCER COVER is the device name listed in this FDA 510(k) record. The listed applicant is Amedic AB. It received FDA 510(k) clearance on 1997-12-30 under 510(k) number K955893. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVERYTIME TRANSFUCER COVER?

EVERYTIME TRANSFUCER COVER is a medical device that received FDA 510(k) clearance on 1997-12-30. The listed applicant is Amedic AB. The 510(k) number is K955893.

When did EVERYTIME TRANSFUCER COVER receive FDA 510(k) clearance?

EVERYTIME TRANSFUCER COVER received FDA 510(k) clearance on 1997-12-30, under 510(k) number K955893.

Who is the listed applicant for EVERYTIME TRANSFUCER COVER?

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

What is the FDA product code for EVERYTIME TRANSFUCER COVER?

The FDA product code for EVERYTIME TRANSFUCER COVER is ITX.

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Related Devices (Code: ITX)

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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