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FDA 510(k)

IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X

K-Number: K050751 · 2005-04-21

ApplicantAgfa Corp.
Decision Date2005-04-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Corp.. It received FDA 510(k) clearance on 2005-04-21 under 510(k) number K050751. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X?

IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X is a medical device that received FDA 510(k) clearance on 2005-04-21. The listed applicant is Agfa Corp.. The 510(k) number is K050751.

When did IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X receive FDA 510(k) clearance?

IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X received FDA 510(k) clearance on 2005-04-21, under 510(k) number K050751.

Who is the listed applicant for IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X?

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

What is the FDA product code for IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X?

The FDA product code for IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X is LLZ.

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Other records listing Agfa Corp. as applicant

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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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