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FDA 510(k)

DIGIGRAPH DIAGNOSTIC WORK/STATION

K-Number: K896099 · 1991-01-31

ApplicantDolphin Imaging Systems
Decision Date1991-01-31
Product CodeEAG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGIGRAPH DIAGNOSTIC WORK/STATION is the device name listed in this FDA 510(k) record. The listed applicant is Dolphin Imaging Systems. It received FDA 510(k) clearance on 1991-01-31 under 510(k) number K896099. The device is classified under product code EAG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGIGRAPH DIAGNOSTIC WORK/STATION?

DIGIGRAPH DIAGNOSTIC WORK/STATION is a medical device that received FDA 510(k) clearance on 1991-01-31. The listed applicant is Dolphin Imaging Systems. The 510(k) number is K896099.

When did DIGIGRAPH DIAGNOSTIC WORK/STATION receive FDA 510(k) clearance?

DIGIGRAPH DIAGNOSTIC WORK/STATION received FDA 510(k) clearance on 1991-01-31, under 510(k) number K896099.

Who is the listed applicant for DIGIGRAPH DIAGNOSTIC WORK/STATION?

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

What is the FDA product code for DIGIGRAPH DIAGNOSTIC WORK/STATION?

The FDA product code for DIGIGRAPH DIAGNOSTIC WORK/STATION is EAG.

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Related Devices (Code: EAG)

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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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