AIRSTRIP OB

System, Monitoring, Perinatal

AIRSTRIP TECHNOLOGIES, LP

The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Ob.

Pre-market Notification Details

Device IDK090061
510k NumberK090061
Device Name:AIRSTRIP OB
ClassificationSystem, Monitoring, Perinatal
Applicant AIRSTRIP TECHNOLOGIES, LP 3303 OAKWELL CT., SUITE 200 San Antonio,  TX  78218
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeHGM  
CFR Regulation Number884.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-01-09
Decision Date2009-01-23

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