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FDA 510(k)

DYNAWELL OR DYNAWELL

K-Number: K992120 · 1999-08-13

ApplicantEkeroth Quality AB
Decision Date1999-08-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DYNAWELL OR DYNAWELL is the device name listed in this FDA 510(k) record. The listed applicant is Ekeroth Quality AB. It received FDA 510(k) clearance on 1999-08-13 under 510(k) number K992120. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYNAWELL OR DYNAWELL?

DYNAWELL OR DYNAWELL is a medical device that received FDA 510(k) clearance on 1999-08-13. The listed applicant is Ekeroth Quality AB. The 510(k) number is K992120.

When did DYNAWELL OR DYNAWELL receive FDA 510(k) clearance?

DYNAWELL OR DYNAWELL received FDA 510(k) clearance on 1999-08-13, under 510(k) number K992120.

Who is the listed applicant for DYNAWELL OR DYNAWELL?

The FDA 510(k) record lists Ekeroth Quality AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAWELL OR DYNAWELL?

The FDA product code for DYNAWELL OR DYNAWELL is LNH.

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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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