CapMedic

Nebulizer (direct Patient Interface)

Cognita Labs, LLC

The following data is part of a premarket notification filed by Cognita Labs, Llc with the FDA for Capmedic.

Pre-market Notification Details

Device IDK183586
510k NumberK183586
Device Name:CapMedic
ClassificationNebulizer (direct Patient Interface)
Applicant Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana,  CA  92701
ContactRajoshi Biswas
CorrespondentRajoshi Biswas
Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana,  CA  92701
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-21
Decision Date2019-09-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860003953709 K183586 000

Trademark Results [CapMedic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPMEDIC
CAPMEDIC
86820667 5885618 Live/Registered
Cognita Labs, LLC
2015-11-15

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