Propeller System 2014-R

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 2014-r.

Pre-market Notification Details

Device IDK142960
510k NumberK142960
Device Name:Propeller System 2014-R
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 Received2014-10-14
Decision Date2015-03-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865528000020 K142960 000

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