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510(k) Data Aggregation
K Number
K042082Device Name
AIRSTRIP OB
Manufacturer
Date Cleared
2005-01-21
(171 days)
Product Code
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
MP4 SOLUTIONS, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
AirStrip OB® is intended to be used by Obstetricians for the following purposes:
- To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction by viewing the real time waveforms remotely using a mobile device such as a PDA or Smart Phone
- To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time.
- To review the current Labor and Delivery patient census list.
- Provide a request for remote consultation regarding a fetal heart tracing.
- To remotely review other standard or critical real-time numeric data from Labor and Delivery.
Device Description
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