FLEXI-LITE, MODEL FL-V1.2

Chamber, Hyperbaric

PERFORMANCE HYPERBARICS

The following data is part of a premarket notification filed by Performance Hyperbarics with the FDA for Flexi-lite, Model Fl-v1.2.

Pre-market Notification Details

Device IDK051759
510k NumberK051759
Device Name:FLEXI-LITE, MODEL FL-V1.2
ClassificationChamber, Hyperbaric
Applicant PERFORMANCE HYPERBARICS 2599 A OLINDA ROAD Makawao,  HI  96768
ContactSpencer Feldman
CorrespondentSpencer Feldman
PERFORMANCE HYPERBARICS 2599 A OLINDA ROAD Makawao,  HI  96768
Product CodeCBF  
CFR Regulation Number868.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-29
Decision Date2005-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865439000270 K051759 000
00852834007010 K051759 000
00852834007027 K051759 000
00852834007034 K051759 000
00852834007041 K051759 000
00852834007058 K051759 000
00865439000201 K051759 000
00865439000218 K051759 000
00865439000225 K051759 000
00865439000232 K051759 000
00865439000249 K051759 000
00865439000256 K051759 000
00865439000263 K051759 000
00852834007003 K051759 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.