FDA 510(k)

CR-PRO

K-Number: K052938 · 2005-11-17

Decision Date2005-11-17

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CR-PRO is the device name listed in this FDA 510(k) record. The listed applicant is Eradlink, Inc.. It received FDA 510(k) clearance on 2005-11-17 under 510(k) number K052938. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CR-PRO?

CR-PRO is a medical device that received FDA 510(k) clearance on 2005-11-17. The listed applicant is Eradlink, Inc.. The 510(k) number is K052938.

When did CR-PRO receive FDA 510(k) clearance?

CR-PRO received FDA 510(k) clearance on 2005-11-17, under 510(k) number K052938.

Who is the listed applicant for CR-PRO?

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

What is the FDA product code for CR-PRO?

The FDA product code for CR-PRO is MQB.

Other records listing Eradlink, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K020243LASERPRO 16

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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.