Home / 510(k) Clearances / K191401

510(k) K191401

PregSense by Nuvo- Group , Ltd. — Product Code LQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2020
Date Received
May 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Home Uterine Activity Monitor
Device Class
Class II
Regulation Number
884.2730
Review Panel
OB
Submission Type

Other clearances by Nuvo- Group , Ltd.

  • K221046 — Invu by Nuvo (May 6, 2022)
  • K210025 — INVU by Nuvo (May 28, 2021)

Other clearances for product code LQK

  • K221046 — Invu by Nuvo (May 6, 2022)
  • K210025 — INVU by Nuvo (May 28, 2021)
  • K143114 — Sense4Baby System Model B+ (MSA) (March 10, 2015)
  • K020390 — MODIFICATION TO FETAL ASSIST (April 19, 2002)