SLEEPAP

Ventilator, Non-continuous (respirator)

MEDICAL INDUSTRIES AMERICA, INC.

The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for Sleepap.

Pre-market Notification Details

Device IDK905593
510k NumberK905593
Device Name:SLEEPAP
ClassificationVentilator, Non-continuous (respirator)
Applicant MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel,  IA  50003
ContactRussell F Bird
CorrespondentRussell F Bird
MEDICAL INDUSTRIES AMERICA, INC. 2875 R AVE. Adel,  IA  50003
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-13
Decision Date1991-04-23

Trademark Results [SLEEPAP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SLEEPAP
SLEEPAP
88016916 5675137 Live/Registered
Encompass Group, LLC
2018-06-27

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