IT NASAL MASK

Ventilator, Non-continuous (respirator)

INNOMED TECHNOLOGIES

The following data is part of a premarket notification filed by Innomed Technologies with the FDA for It Nasal Mask.

Pre-market Notification Details

Device IDK050171
510k NumberK050171
Device Name:IT NASAL MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant INNOMED TECHNOLOGIES 6601 LYONS ROAD SUITES B1-B-4 Coconut Creek,  FL  33073
ContactFrank Pelc
CorrespondentFrank Pelc
INNOMED TECHNOLOGIES 6601 LYONS ROAD SUITES B1-B-4 Coconut Creek,  FL  33073
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-26
Decision Date2005-05-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10607411945547 K050171 000
10607411942133 K050171 000
10607411942140 K050171 000
10607411942157 K050171 000
10607411942164 K050171 000
10607411942171 K050171 000
10607411942188 K050171 000
10607411942195 K050171 000
10607411945479 K050171 000
10607411945486 K050171 000
10607411945493 K050171 000
10607411945509 K050171 000
10607411945516 K050171 000
10607411945523 K050171 000
10607411945530 K050171 000
10607411942126 K050171 000

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