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510(k) K020390

MODIFICATION TO FETAL ASSIST by Huntleigh Diagnostics , Ltd. — Product Code LQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2002
Date Received
February 6, 2002
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 Huntleigh Diagnostics , Ltd.

  • K002548 — FETAL ASSIST (March 6, 2001)
  • K001677 — BABY DOPPLEX 4000 (BD4000) (August 14, 2000)

Other clearances for product code LQK

  • K221046 — Invu by Nuvo (May 6, 2022)
  • K210025 — INVU by Nuvo (May 28, 2021)
  • K191401 — PregSense (March 27, 2020)
  • K143114 — Sense4Baby System Model B+ (MSA) (March 10, 2015)