OrthoAnalysis Software
K-Number: K183695 · 2019-09-12
ApplicantInteware Co., Ltd.
Decision Date2019-09-12
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OrthoAnalysis Software is a medical device manufactured by Inteware Co., Ltd.. It received FDA 510(k) clearance on 2019-09-12 under approval number K183695. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OrthoAnalysis Software?
OrthoAnalysis Software is a medical device that received FDA 510(k) clearance on 2019-09-12. It is manufactured by Inteware Co., Ltd.. The 510(k) number is K183695.
When was OrthoAnalysis Software approved by the FDA?
OrthoAnalysis Software received FDA 510(k) clearance on 2019-09-12, under approval number K183695.
What company makes OrthoAnalysis Software?
OrthoAnalysis Software is manufactured by Inteware Co., Ltd..
What is the FDA product code for OrthoAnalysis Software?
The FDA product code for OrthoAnalysis Software is PNN.
Other Devices by Inteware Co., Ltd.
Related Devices (Code: PNN)
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.