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510(k) K020390

Device
MODIFICATION TO FETAL ASSIST
Applicant
HUNTLEIGH DIAGNOSTICS LTD.
510(k) number
K020390
Product code
LQK  
Decision
Substantially Equivalent (SESE)
Decision date
2002-04-19
Date received
2002-02-06
Regulation
884.2730
Classification name
Home Uterine Activity Monitor
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
AUDREY WITKO
Address
40 Christopher Way Eatontown NJ US 07724 07724

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LQK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221046Invu by NuvoNuvo- Group , Ltd.2022-05-06
K210025INVU by NuvoNuvo- Group , Ltd.2021-05-28
K191401PregSenseNuvo- Group , Ltd.2020-03-27
K143114Sense4Baby System Model B+ (MSA)Airstrip Technologies, Inc.2015-03-10

Legacy Summary#

summary

FDA Review#

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