VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1

Ventilator, Continuous, Facility Use

PAN-AMERICA HYPERBARICS, INC.

The following data is part of a premarket notification filed by Pan-america Hyperbarics, Inc. with the FDA for Versalvent Model V1 Hyperbaric Chamber Ventilator Model V1.

Pre-market Notification Details

Device IDK122560
510k NumberK122560
Device Name:VERSALVENT MODEL V1 HYPERBARIC CHAMBER VENTILATOR MODEL V1
ClassificationVentilator, Continuous, Facility Use
Applicant PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE Atchison,  KS  66002
ContactWilliam M Gates, Rrt
CorrespondentWilliam M Gates, Rrt
PAN-AMERICA HYPERBARICS, INC. 1510 PARK PLACE DRIVE Atchison,  KS  66002
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-08-22
Decision Date2013-03-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719872000006 K122560 000

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