MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

Generator, Oxygen, Portable

MERITS HEALTH PRODUCTS., INC.

The following data is part of a premarket notification filed by Merits Health Products., Inc. with the FDA for Merits Health Products Oxygen Concentrators.

Pre-market Notification Details

Device IDK011844
510k NumberK011844
Device Name:MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
ClassificationGenerator, Oxygen, Portable
Applicant MERITS HEALTH PRODUCTS., INC. 7690 CAMERON CIRCLE Fort Myers,  FL  33912
ContactLee Leichter
CorrespondentLee Leichter
MERITS HEALTH PRODUCTS., INC. 7690 CAMERON CIRCLE Fort Myers,  FL  33912
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-06-12
Decision Date2001-08-28
Summary:summary

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