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FDA 510(k)

DISCAM DIGITAL IMAGING SYSTEM

K-Number: K974535 · 1998-08-14

ApplicantMarcher Enterprises, Ltd.
Decision Date1998-08-14
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISCAM DIGITAL IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Marcher Enterprises, Ltd.. It received FDA 510(k) clearance on 1998-08-14 under 510(k) number K974535. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISCAM DIGITAL IMAGING SYSTEM?

DISCAM DIGITAL IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-08-14. The listed applicant is Marcher Enterprises, Ltd.. The 510(k) number is K974535.

When did DISCAM DIGITAL IMAGING SYSTEM receive FDA 510(k) clearance?

DISCAM DIGITAL IMAGING SYSTEM received FDA 510(k) clearance on 1998-08-14, under 510(k) number K974535.

Who is the listed applicant for DISCAM DIGITAL IMAGING SYSTEM?

The FDA 510(k) record lists Marcher Enterprises, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DISCAM DIGITAL IMAGING SYSTEM?

The FDA product code for DISCAM DIGITAL IMAGING SYSTEM is HKI.

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Official Source

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