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FDA 510(k)

DIGORA PCT/DIGIPOD

K-Number: K070304 · 2007-03-27

ApplicantSoredex Palodex Group OY
Decision Date2007-03-27
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DIGORA PCT/DIGIPOD 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 2007-03-27 under 510(k) number K070304. 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 PCT/DIGIPOD?

DIGORA PCT/DIGIPOD is a medical device that received FDA 510(k) clearance on 2007-03-27. The listed applicant is Soredex Palodex Group OY. The 510(k) number is K070304.

When did DIGORA PCT/DIGIPOD receive FDA 510(k) clearance?

DIGORA PCT/DIGIPOD received FDA 510(k) clearance on 2007-03-27, under 510(k) number K070304.

Who is the listed applicant for DIGORA PCT/DIGIPOD?

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 PCT/DIGIPOD?

The FDA product code for DIGORA PCT/DIGIPOD is MUH.

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Other records listing Soredex Palodex Group OY as applicant

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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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