The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Vacuvest Respiratory Support System.
| Device ID | K895849 |
| 510k Number | K895849 |
| Device Name: | RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| 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 | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-03 |
| Decision Date | 1989-12-22 |