MODIFICATION TO NASAL-AIRE

Ventilator, Non-continuous (respirator)

INNOMED TECHNOLOGIES

The following data is part of a premarket notification filed by Innomed Technologies with the FDA for Modification To Nasal-aire.

Pre-market Notification Details

Device IDK022465
510k NumberK022465
Device Name:MODIFICATION TO NASAL-AIRE
ClassificationVentilator, Non-continuous (respirator)
Applicant INNOMED TECHNOLOGIES 506 GARDEN STREET Greensburg,  PA  15601
ContactMarge Walls-walker
CorrespondentMarge Walls-walker
INNOMED TECHNOLOGIES 506 GARDEN STREET Greensburg,  PA  15601
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-26
Decision Date2003-03-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10607411942263 K022465 000
10607411940795 K022465 000
10607411942065 K022465 000
10607411942072 K022465 000
10607411942089 K022465 000
10607411942096 K022465 000
10607411942102 K022465 000
10607411942119 K022465 000
10607411942201 K022465 000
10607411942218 K022465 000
10607411942225 K022465 000
10607411942232 K022465 000
10607411942249 K022465 000
10607411942256 K022465 000
10607411940788 K022465 000

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