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FDA 510(k)

ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032

K-Number: K071673 · 2007-07-18

ApplicantOnc Solutions, Inc.
Decision Date2007-07-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 is the device name listed in this FDA 510(k) record. The listed applicant is Onc Solutions, Inc.. It received FDA 510(k) clearance on 2007-07-18 under 510(k) number K071673. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032?

ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 is a medical device that received FDA 510(k) clearance on 2007-07-18. The listed applicant is Onc Solutions, Inc.. The 510(k) number is K071673.

When did ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 receive FDA 510(k) clearance?

ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 received FDA 510(k) clearance on 2007-07-18, under 510(k) number K071673.

Who is the listed applicant for ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032?

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

What is the FDA product code for ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032?

The FDA product code for ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032 is IYE.

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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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