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FDA 510(k)

INTRA SKAN DC

K-Number: K103579 · 2011-03-18

ApplicantSkanray Technologies
Decision Date2011-03-18
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTRA SKAN DC is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K103579. 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 INTRA SKAN DC?

INTRA SKAN DC is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Skanray Technologies. The 510(k) number is K103579.

When did INTRA SKAN DC receive FDA 510(k) clearance?

INTRA SKAN DC received FDA 510(k) clearance on 2011-03-18, under 510(k) number K103579.

Who is the listed applicant for INTRA SKAN DC?

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

What is the FDA product code for INTRA SKAN DC?

The FDA product code for INTRA SKAN DC is EHD.

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Other records listing Skanray Technologies 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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