The following data is part of a premarket notification filed by Carleton Life Support Systems Inc. with the FDA for Deployable Oxygen Generation System - Medium (dogs-m).
| Device ID | K071904 |
| 510k Number | K071904 |
| Device Name: | DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M) |
| Classification | Generator, Oxygen, Portable |
| Applicant | CARLETON LIFE SUPPORT SYSTEMS INC. 2734 HICKORY GROVE RD. Davenport, IA 52804 -1203 |
| Contact | Gary Byrd |
| Correspondent | Gary Byrd CARLETON LIFE SUPPORT SYSTEMS INC. 2734 HICKORY GROVE RD. Davenport, IA 52804 -1203 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-10 |
| Decision Date | 2007-10-25 |
| Summary: | summary |