REUSABLE HEADREST WITH NASAL SEAL

Ventilator, Non-continuous (respirator)

AEIOMED, INC.

The following data is part of a premarket notification filed by Aeiomed, Inc. with the FDA for Reusable Headrest With Nasal Seal.

Pre-market Notification Details

Device IDK072993
510k NumberK072993
Device Name:REUSABLE HEADREST WITH NASAL SEAL
ClassificationVentilator, Non-continuous (respirator)
Applicant AEIOMED, INC. 800 LEVANGER LANE Stoughton,  WI  53589
ContactGary Syring
CorrespondentGary Syring
AEIOMED, INC. 800 LEVANGER LANE Stoughton,  WI  53589
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-10-23
Decision Date2008-02-08
Summary:summary

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