T CLASS HYPERBARIC FACILITIES

Chamber, Hyperbaric

REIMERS SYSTEMS, INC.

The following data is part of a premarket notification filed by Reimers Systems, Inc. with the FDA for T Class Hyperbaric Facilities.

Pre-market Notification Details

Device IDK954387
510k NumberK954387
Device Name:T CLASS HYPERBARIC FACILITIES
ClassificationChamber, Hyperbaric
Applicant REIMERS SYSTEMS, INC. 7668 FULLERTON RD. Springfield,  VA  22153 -2818
ContactStephen D Reimers
CorrespondentStephen D Reimers
REIMERS SYSTEMS, INC. 7668 FULLERTON RD. Springfield,  VA  22153 -2818
Product CodeCBF  
CFR Regulation Number868.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-19
Decision Date1995-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850011262009 K954387 000

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