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.
Device ID | K061414 |
510k Number | K061414 |
Device Name: | EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD |
Classification | Generator, Oxygen, Portable |
Applicant | PACIFIC CONSOLIDATED INDUSTRIES, LLC 12201 MAGNOLIA AVE. Riverside, CA 92503 |
Contact | Gary Clark |
Correspondent | Gary Clark PACIFIC CONSOLIDATED INDUSTRIES, LLC 12201 MAGNOLIA AVE. Riverside, CA 92503 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-22 |
Decision Date | 2007-01-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860007698224 | K061414 | 000 |
00860007698217 | K061414 | 000 |
00860007698200 | K061414 | 000 |