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Monica Novii Wireless Patch System

by Monica Healthcare

510(k) K140862

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140862 Date27 Aug 2014ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1292-2018 FDA Class II initiated 15 Dec 2017

    if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).

    • Terminated Z-2588-2017 FDA Class II initiated 28 Apr 2017

    Monica Novii Wireless Patch System-Potential battery damage and excess heat through prolonged charging.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OSP
FDA applicant
Monica Healthcare, Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.2720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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