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 |