The following data is part of a premarket notification filed by Devilbiss Health Care, Inc. with the FDA for 5 Lpm Oxygen Concentrator.
| Device ID | K953815 |
| 510k Number | K953815 |
| Device Name: | 5 LPM OXYGEN CONCENTRATOR |
| Classification | Generator, Oxygen, Portable |
| Applicant | DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Contact | Greg Clites |
| Correspondent | Greg Clites DEVILBISS HEALTH CARE, INC. 1200 EAST MAIN ST. P.O.BOX 635 Somerset, PA 15501 -0635 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-14 |
| Decision Date | 1995-11-09 |