The following data is part of a premarket notification filed by Pacific Consolidated Industries, Llc with the FDA for Deployable Oxygen Concentration System (docs), Model 66, Deployable Oxygen Ceoncentration.
Device ID | K100957 |
510k Number | K100957 |
Device Name: | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION |
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 | 2010-04-07 |
Decision Date | 2011-01-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860007698248 | K100957 | 000 |