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FDA 510(k)

AXIAL TOME, 60, FLUORO AND TOMAX

K-Number: K872825 · 1988-03-31

ApplicantAxialtome Corp.
Decision Date1988-03-31
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AXIAL TOME, 60, FLUORO AND TOMAX is the device name listed in this FDA 510(k) record. The listed applicant is Axialtome Corp.. It received FDA 510(k) clearance on 1988-03-31 under 510(k) number K872825. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIAL TOME, 60, FLUORO AND TOMAX?

AXIAL TOME, 60, FLUORO AND TOMAX is a medical device that received FDA 510(k) clearance on 1988-03-31. The listed applicant is Axialtome Corp.. The 510(k) number is K872825.

When did AXIAL TOME, 60, FLUORO AND TOMAX receive FDA 510(k) clearance?

AXIAL TOME, 60, FLUORO AND TOMAX received FDA 510(k) clearance on 1988-03-31, under 510(k) number K872825.

Who is the listed applicant for AXIAL TOME, 60, FLUORO AND TOMAX?

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

What is the FDA product code for AXIAL TOME, 60, FLUORO AND TOMAX?

The FDA product code for AXIAL TOME, 60, FLUORO AND TOMAX is EHD.

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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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