The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Modified Sanders Bi-papeasy.
| Device ID | K883825 |
| 510k Number | K883825 |
| Device Name: | MODIFIED SANDERS BI-PAPEASY |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Eugene N Scarberry |
| Correspondent | Eugene N Scarberry RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-09 |
| Decision Date | 1988-12-08 |