The following data is part of a premarket notification filed by Sims Portex, Inc. with the FDA for Cpap System, Model 102001.
| Device ID | K001318 |
| 510k Number | K001318 |
| Device Name: | CPAP SYSTEM, MODEL 102001 |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Contact | Brian D Farias |
| Correspondent | Brian D Farias SIMS PORTEX, INC. 10 BOWMAN DR. Keene, NH 03431 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-26 |
| Decision Date | 2000-07-20 |