The following data is part of a premarket notification filed by Pacific Consolidated Industries Llp with the FDA for Deployable Oxygen Concentration System (docs).
Device ID | K020330 |
510k Number | K020330 |
Device Name: | DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS) |
Classification | Generator, Oxygen, Portable |
Applicant | PACIFIC CONSOLIDATED INDUSTRIES LLP 3430 WEST CARRIAGE DR. Santa Ana, CA 92704 |
Contact | Lee W Smith |
Correspondent | Lee W Smith PACIFIC CONSOLIDATED INDUSTRIES LLP 3430 WEST CARRIAGE DR. Santa Ana, CA 92704 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-31 |
Decision Date | 2002-04-12 |
Summary: | summary |