The following data is part of a premarket notification filed by Carleton Life Support Systems Inc. with the FDA for Patient Ventilation Oxygen Concentrating System, High Flow (pvocs Hf).
| Device ID | K051887 |
| 510k Number | K051887 |
| Device Name: | PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) |
| 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 | 2005-07-12 |
| Decision Date | 2005-09-27 |
| Summary: | summary |