FDA 510(k)

PregSense

K-Number: K191401 · 2020-03-27

Decision Date2020-03-27

Product CodeLQK

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

PregSense is the device name listed in this FDA 510(k) record. The listed applicant is Nuvo- Group , Ltd.. It received FDA 510(k) clearance on 2020-03-27 under 510(k) 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. The listed applicant is Nuvo- Group , Ltd.. The 510(k) number is K191401.

When did PregSense receive FDA 510(k) clearance?

PregSense received FDA 510(k) clearance on 2020-03-27, under 510(k) number K191401.

Who is the listed applicant for PregSense?

The FDA 510(k) record lists Nuvo- Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PregSense?

The FDA product code for PregSense is LQK.

Other records listing Nuvo- Group , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221046Invu by Nuvo K210025INVU by Nuvo

Related Devices (Code: LQK)

K221046Invu by NuvoNuvo- Group , Ltd.K210025INVU by NuvoNuvo- Group , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.