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FDA 510(k)

PALAMED

K-Number: K030904 · 2003-09-23

ApplicantHeraeus Medical GmbH Technology
Decision Date2003-09-23
Product CodeLOD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PALAMED is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Medical GmbH Technology. It received FDA 510(k) clearance on 2003-09-23 under 510(k) number K030904. The device is classified under product code LOD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALAMED?

PALAMED is a medical device that received FDA 510(k) clearance on 2003-09-23. The listed applicant is Heraeus Medical GmbH Technology. The 510(k) number is K030904.

When did PALAMED receive FDA 510(k) clearance?

PALAMED received FDA 510(k) clearance on 2003-09-23, under 510(k) number K030904.

Who is the listed applicant for PALAMED?

The FDA 510(k) record lists Heraeus Medical GmbH Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PALAMED?

The FDA product code for PALAMED is LOD.

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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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