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FDA 510(k)

DIGORA FOR WINDOWS 2.0

K-Number: K983267 · 1998-12-30

ApplicantOrion Corporation Soredex
Decision Date1998-12-30
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGORA FOR WINDOWS 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corporation Soredex. It received FDA 510(k) clearance on 1998-12-30 under 510(k) number K983267. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIGORA FOR WINDOWS 2.0?

DIGORA FOR WINDOWS 2.0 is a medical device that received FDA 510(k) clearance on 1998-12-30. The listed applicant is Orion Corporation Soredex. The 510(k) number is K983267.

When did DIGORA FOR WINDOWS 2.0 receive FDA 510(k) clearance?

DIGORA FOR WINDOWS 2.0 received FDA 510(k) clearance on 1998-12-30, under 510(k) number K983267.

Who is the listed applicant for DIGORA FOR WINDOWS 2.0?

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

What is the FDA product code for DIGORA FOR WINDOWS 2.0?

The FDA product code for DIGORA FOR WINDOWS 2.0 is MUH.

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Other records listing Orion Corporation Soredex 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.

K974877CRANEX TOME CEPH, OR CRANEX TOMEK934949DIGORAK880982ORALIX PAN DC III CEPH OR PANORAMIC MODE ONLY

Related Devices (Code: MUH)

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

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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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