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FDA 510(k)

SCANRITE DFS

K-Number: K970850 · 1997-05-14

ApplicantScanrite Systems
Decision Date1997-05-14
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SCANRITE DFS is the device name listed in this FDA 510(k) record. The listed applicant is Scanrite Systems. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K970850. 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 SCANRITE DFS?

SCANRITE DFS is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Scanrite Systems. The 510(k) number is K970850.

When did SCANRITE DFS receive FDA 510(k) clearance?

SCANRITE DFS received FDA 510(k) clearance on 1997-05-14, under 510(k) number K970850.

Who is the listed applicant for SCANRITE DFS?

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

What is the FDA product code for SCANRITE DFS?

The FDA product code for SCANRITE DFS 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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