PregSense
K-Number: K191401 · 2020-03-27
ApplicantNuvo- Group , Ltd.
Decision Date2020-03-27
Product CodeLQK
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
PregSense is a medical device manufactured by Nuvo- Group , Ltd.. It received FDA 510(k) clearance on 2020-03-27 under approval number K191401. The device is classified under product code LQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PregSense?
PregSense is a medical device that received FDA 510(k) clearance on 2020-03-27. It is manufactured by Nuvo- Group , Ltd.. The 510(k) number is K191401.
When was PregSense approved by the FDA?
PregSense received FDA 510(k) clearance on 2020-03-27, under approval number K191401.
What company makes PregSense?
PregSense is manufactured by Nuvo- Group , Ltd..
What is the FDA product code for PregSense?
The FDA product code for PregSense is LQK.
Other Devices by Nuvo- Group , Ltd.
Related Devices (Code: LQK)
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.