O-PEP

Spirometer, Therapeutic (incentive)

PARI RESPIRATORY EQUIPMENT, INC.

The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for O-pep.

Pre-market Notification Details

Device IDK150044
510k NumberK150044
Device Name:O-PEP
ClassificationSpirometer, Therapeutic (incentive)
Applicant PARI RESPIRATORY EQUIPMENT, INC. 2412 PARI Way Midlothian,  VA  23112
ContactMichael Judge
CorrespondentMichael Judge
PARI RESPIRATORY EQUIPMENT, INC. 2412 PARI Way Midlothian,  VA  23112
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-12
Decision Date2016-05-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00744229100010 K150044 000

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