Sense4Baby System Model B+ (MSA)— 510(k) K143114

Clearance details

Applicant

Airstrip Technologies, Inc.

Product code

Code LQK

Device class

Class 2

Regulation

21 CFR 884.2730

Advisory panel

Obstetrics/Gynecology

Date received

2014-10-30

Decision date

2015-03-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

La Jolla, CA, US

• K253673 — Mcare System (MW-20)2026-09-03
• K221046 — Invu by Nuvo2022-05-06
• K210025 — INVU by Nuvo2021-05-28
• K191401 — PregSense2020-03-27
• K020390 — MODIFICATION TO FETAL ASSIST2002-04-19

• K211949 — AirStrip ONE Web Client with Alarm Communication Management (ACM)2021-12-09
• K182226 — AirStrip RPM InvisionHeart Adapter2018-09-11
• K160862 — AirStrip RPM2016-09-19
• K121712 — AIRSTRIP RPM FOR LIFENET CONSULT2012-11-20

• Z-2829-2016 — AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model C is indicated for monitoring of maternal and fetal physiologic parameters during the antepartum period. The Sense4Baby System is to be used by health care professionals or patients, by prescription or doctor s order, in hospitals, clinics, physicians offices, antepartum rooms, or outside a hospital or health care setting. The data interpretation is to be done by a health care professional.Class II·Terminated·AirStrip Technologies, Inc.·20160804

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143114.