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FDA 510(k)

RAYPAX SYSTEM

K-Number: K081948 · 2008-09-19

ApplicantRaypax, Inc.
Decision Date2008-09-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RAYPAX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Raypax, Inc.. It received FDA 510(k) clearance on 2008-09-19 under 510(k) number K081948. 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 RAYPAX SYSTEM?

RAYPAX SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-19. The listed applicant is Raypax, Inc.. The 510(k) number is K081948.

When did RAYPAX SYSTEM receive FDA 510(k) clearance?

RAYPAX SYSTEM received FDA 510(k) clearance on 2008-09-19, under 510(k) number K081948.

Who is the listed applicant for RAYPAX SYSTEM?

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

What is the FDA product code for RAYPAX SYSTEM?

The FDA product code for RAYPAX SYSTEM is LLZ.

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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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