PUREtrace
K-Number: K153262 · 2017-02-07
ApplicantNemo Healthcare BV
Decision Date2017-02-07
Product CodeOSP
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
PUREtrace is a medical device manufactured by Nemo Healthcare BV. It received FDA 510(k) clearance on 2017-02-07 under approval number K153262. The device is classified under product code OSP. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PUREtrace?
PUREtrace is a medical device that received FDA 510(k) clearance on 2017-02-07. It is manufactured by Nemo Healthcare BV. The 510(k) number is K153262.
When was PUREtrace approved by the FDA?
PUREtrace received FDA 510(k) clearance on 2017-02-07, under approval number K153262.
What company makes PUREtrace?
PUREtrace is manufactured by Nemo Healthcare BV.
What is the FDA product code for PUREtrace?
The FDA product code for PUREtrace is OSP.
Related Devices (Code: OSP)
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.