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FDA 510(k)

DIGORA OPTIME (OR DIGORA ONTIME)

K-Number: K041050 · 2004-06-15

ApplicantSoredex Palodex Group OY
Decision Date2004-06-15
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGORA OPTIME (OR DIGORA ONTIME) is the device name listed in this FDA 510(k) record. The listed applicant is Soredex Palodex Group OY. It received FDA 510(k) clearance on 2004-06-15 under 510(k) number K041050. 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 OPTIME (OR DIGORA ONTIME)?

DIGORA OPTIME (OR DIGORA ONTIME) is a medical device that received FDA 510(k) clearance on 2004-06-15. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K041050.

When did DIGORA OPTIME (OR DIGORA ONTIME) receive FDA 510(k) clearance?

DIGORA OPTIME (OR DIGORA ONTIME) received FDA 510(k) clearance on 2004-06-15, under 510(k) number K041050.

Who is the listed applicant for DIGORA OPTIME (OR DIGORA ONTIME)?

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

What is the FDA product code for DIGORA OPTIME (OR DIGORA ONTIME)?

The FDA product code for DIGORA OPTIME (OR DIGORA ONTIME) is MUH.

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Other records listing Soredex Palodex Group OY 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.

K110839SCANORA 3DK073350SCANORA 3DK070304DIGORA PCT/DIGIPODK063459CRANEX NOVUSK043307CRANEX DK040382CRANEX BASEX D OR CRANEX EXCEL D

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Related Devices (Code: MUH)

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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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