FRASER HARLAKE HOPE III RESUSCITATOR

Ventilator, Emergency, Manual (resuscitator)

FRASER HARLAKE, INC.

The following data is part of a premarket notification filed by Fraser Harlake, Inc. with the FDA for Fraser Harlake Hope Iii Resuscitator.

Pre-market Notification Details

Device IDK841496
510k NumberK841496
Device Name:FRASER HARLAKE HOPE III RESUSCITATOR
ClassificationVentilator, Emergency, Manual (resuscitator)
Applicant FRASER HARLAKE, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBTM  
CFR Regulation Number868.5915 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-04-10
Decision Date1984-04-24

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