RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD

Ventilator, Continuous, Facility Use

INNOMED TECHNOLOGIES INC./RESPCARE INC.

The following data is part of a premarket notification filed by Innomed Technologies Inc./respcare Inc. with the FDA for Respcare Hybrid Ne Face Mask, Model Tbd,; Disposable, Model Tbd.

Pre-market Notification Details

Device IDK062019
510k NumberK062019
Device Name:RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
ClassificationVentilator, Continuous, Facility Use
Applicant INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek,  FL  33073
ContactFrank Pelc
CorrespondentFrank Pelc
INNOMED TECHNOLOGIES INC./RESPCARE INC. 6601 LYONS ROAD SUITES B1-B4 Coconut Creek,  FL  33073
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-17
Decision Date2006-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10607411945738 K062019 000
10607411943789 K062019 000
10607411943796 K062019 000
10607411943802 K062019 000
10607411943819 K062019 000
10607411943826 K062019 000
10607411945622 K062019 000
10607411945639 K062019 000
10607411945646 K062019 000
10607411945653 K062019 000
10607411945660 K062019 000
10607411945677 K062019 000
10607411945714 K062019 000
10607411945721 K062019 000
10607411943772 K062019 000

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