FDA-Device2016-09-21Class II
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.
AirStrip Technologies, Inc.
Hazard
Belt clip may become detached causing electronic components to be exposed.
Sold states
U.S. distribution to the following; AR, LA. Foreign distribution to the following; South Africa, Netherlands.
Affected count
42
Manufactured in
565 Pearl St Ste 209, N/A, La Jolla, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2829-2016Don't want to check this manually?
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