EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD

Generator, Oxygen, Portable

PACIFIC CONSOLIDATED INDUSTRIES, LLC

The following data is part of a premarket notification filed by Pacific Consolidated Industries, Llc with the FDA for Expeditionary Delployable Oxygen Concentration System (edocs), Models 120b And 30;mobile Oxygen Storage Tank (most), Mod.

Pre-market Notification Details

Device IDK061414
510k NumberK061414
Device Name:EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD
ClassificationGenerator, Oxygen, Portable
Applicant PACIFIC CONSOLIDATED INDUSTRIES, LLC 12201 MAGNOLIA AVE. Riverside,  CA  92503
ContactGary Clark
CorrespondentGary Clark
PACIFIC CONSOLIDATED INDUSTRIES, LLC 12201 MAGNOLIA AVE. Riverside,  CA  92503
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-05-22
Decision Date2007-01-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860007698224 K061414 000
00860007698217 K061414 000
00860007698200 K061414 000

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