ExactechGPS System
K-Number: K193618 · 2020-09-02
ApplicantBlue Ortho
Decision Date2020-09-02
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ExactechGPS System is a medical device manufactured by Blue Ortho. It received FDA 510(k) clearance on 2020-09-02 under approval number K193618. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ExactechGPS System?
ExactechGPS System is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Blue Ortho. The 510(k) number is K193618.
When was ExactechGPS System approved by the FDA?
ExactechGPS System received FDA 510(k) clearance on 2020-09-02, under approval number K193618.
What company makes ExactechGPS System?
ExactechGPS System is manufactured by Blue Ortho.
What is the FDA product code for ExactechGPS System?
The FDA product code for ExactechGPS System is OLO.
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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.