INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR

Valve, Non-rebreathing

INTERTECH RESOURCES, INC.

The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Inspiron(r) Breath For Life Emerg. Resuscitator.

Pre-market Notification Details

Device IDK870253
510k NumberK870253
Device Name:INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
ClassificationValve, Non-rebreathing
Applicant INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers,  FL  33905
ContactJames W Pope
CorrespondentJames W Pope
INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers,  FL  33905
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-22
Decision Date1987-03-06

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