AirStrip RPM

System, Network And Communication, Physiological Monitors

AirStrip Technologies, Inc.

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

Pre-market Notification Details

Device IDK160862
510k NumberK160862
Device Name:AirStrip RPM
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant AirStrip Technologies, Inc. 335 E. Sonterra Blvd, Suite 200 San Antonio,  TX  78258
ContactAndy Miller
CorrespondentCurtis M. Egan
Certified Compliance Solutions, Inc. 11665 Avena Place #203 San Diego,  CA  92128 -2504
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-29
Decision Date2016-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B15320100 K160862 000
B15320030 K160862 000

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