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FDA 510(k)

CRANEX BASEX D OR CRANEX EXCEL D

K-Number: K040382 · 2004-07-13

ApplicantSoredex Palodex Group OY
Decision Date2004-07-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CRANEX BASEX D OR CRANEX EXCEL D is the device name listed in this FDA 510(k) record. The listed applicant is Soredex Palodex Group OY. It received FDA 510(k) clearance on 2004-07-13 under 510(k) number K040382. 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 CRANEX BASEX D OR CRANEX EXCEL D?

CRANEX BASEX D OR CRANEX EXCEL D is a medical device that received FDA 510(k) clearance on 2004-07-13. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K040382.

When did CRANEX BASEX D OR CRANEX EXCEL D receive FDA 510(k) clearance?

CRANEX BASEX D OR CRANEX EXCEL D received FDA 510(k) clearance on 2004-07-13, under 510(k) number K040382.

Who is the listed applicant for CRANEX BASEX D OR CRANEX EXCEL D?

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

What is the FDA product code for CRANEX BASEX D OR CRANEX EXCEL D?

The FDA product code for CRANEX BASEX D OR CRANEX EXCEL D is EHD.

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Other records listing Soredex Palodex Group OY as applicant

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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Related Devices (Code: EHD)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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