NovaGuide 2 Intelligent Ultrasound
K-Number: K213279 · 2022-03-02
ApplicantNovasignal Corporation
Decision Date2022-03-02
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
NovaGuide 2 Intelligent Ultrasound is a medical device manufactured by Novasignal Corporation. It received FDA 510(k) clearance on 2022-03-02 under approval number K213279. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NovaGuide 2 Intelligent Ultrasound?
NovaGuide 2 Intelligent Ultrasound is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Novasignal Corporation. The 510(k) number is K213279.
When was NovaGuide 2 Intelligent Ultrasound approved by the FDA?
NovaGuide 2 Intelligent Ultrasound received FDA 510(k) clearance on 2022-03-02, under approval number K213279.
What company makes NovaGuide 2 Intelligent Ultrasound?
NovaGuide 2 Intelligent Ultrasound is manufactured by Novasignal Corporation.
What is the FDA product code for NovaGuide 2 Intelligent Ultrasound?
The FDA product code for NovaGuide 2 Intelligent Ultrasound is IYN.
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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.