AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

AIRSTRIP TECHNOLOGIES, LP

The following data is part of a premarket notification filed by Airstrip Technologies, Lp with the FDA for Airstrip Remote Patient Monitoring Philips Adapter.

Pre-market Notification Details

Device IDK131786
510k NumberK131786
Device Name:AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant AIRSTRIP TECHNOLOGIES, LP 335 E. SONTERRA BLVD. SUITE 200 San Antonio,  TX  78258
ContactRobert Andrew Miller
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2013-06-18
Decision Date2013-07-03

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