Propeller Model 2014-D Sensor

Nebulizer (direct Patient Interface)

Reciprocal Labs

The following data is part of a premarket notification filed by Reciprocal Labs with the FDA for Propeller Model 2014-d Sensor.

Pre-market Notification Details

Device IDK143671
510k NumberK143671
Device Name:Propeller Model 2014-D Sensor
ClassificationNebulizer (direct Patient Interface)
Applicant Reciprocal Labs 634 W. Main Street, Suite 102 Madison,  WI  53703
ContactDavid Hubanks
CorrespondentDavid Hubanks
Reciprocal Labs 634 W. Main Street, Suite 102 Madison,  WI  53703
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-23
Decision Date2015-06-19
Summary:summary

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