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510(k) K210025

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2021
Date Received
January 4, 2021
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)
  • K191401 — PregSense (March 27, 2020)

Other clearances for product code LQK

  • K221046 — Invu by Nuvo (May 6, 2022)
  • K191401 — PregSense (March 27, 2020)
  • K143114 — Sense4Baby System Model B+ (MSA) (March 10, 2015)
  • K020390 — MODIFICATION TO FETAL ASSIST (April 19, 2002)