MEDICAL AIR COMPRESSOR

Compressor, Air, Portable

ORICARE, INC.

The following data is part of a premarket notification filed by Oricare, Inc. with the FDA for Medical Air Compressor.

Pre-market Notification Details

Device IDK113338
510k NumberK113338
Device Name:MEDICAL AIR COMPRESSOR
ClassificationCompressor, Air, Portable
Applicant ORICARE, INC. 1900 AM DRIVE Quakertown,  PA  18951
ContactDavid Jamison
CorrespondentDavid Jamison
ORICARE, INC. 1900 AM DRIVE Quakertown,  PA  18951
Product CodeBTI  
CFR Regulation Number868.6250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-14
Decision Date2012-08-10
Summary:summary

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