Propeller System

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 System.

Pre-market Notification Details

Device IDK142516
510k NumberK142516
Device Name:Propeller System
ClassificationNebulizer (direct Patient Interface)
Applicant RECIPROCAL LABS CORPORATION 634 W Main St Ste 102 Madison,  WI  53703
ContactDavid Hubanks
CorrespondentDavid Hubanks
RECIPROCAL LABS CORPORATION 634 W Main St Ste 102 Madison,  WI  53703
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-08
Decision Date2015-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865528000082 K142516 000
00865528000075 K142516 000
00865528000013 K142516 000

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