Propeller System

Nebulizer (direct Patient Interface)

RECIPROCAL LABS

The following data is part of a premarket notification filed by Reciprocal Labs with the FDA for Propeller System.

Pre-market Notification Details

Device IDK152882
510k NumberK152882
Device Name:Propeller System
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 Received2015-09-30
Decision Date2016-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865528000037 K152882 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.