Propeller Sensor For Neohaler

Nebulizer (direct Patient Interface)

Reciprocal Labs Corporation

The following data is part of a premarket notification filed by Reciprocal Labs Corporation with the FDA for Propeller Sensor For Neohaler.

Pre-market Notification Details

Device IDK180770
510k NumberK180770
Device Name:Propeller Sensor For Neohaler
ClassificationNebulizer (direct Patient Interface)
Applicant Reciprocal Labs Corporation 634 West Main St. Madison,  WI  53703
ContactDavid Hubanks
CorrespondentTaylor Mahan-rudolph
Reciprocal Labs Corporation 634 West Main St. Madison,  WI  53703
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-23
Decision Date2018-08-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865528000099 K180770 000

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