The following data is part of a premarket notification filed by Puritan-bennett with the FDA for Puritan-bennett Companion 320 I/e Bi-level Respiratory System.
| Device ID | K935784 |
| 510k Number | K935784 |
| Device Name: | PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,, KS 66215 |
| Contact | C. Marshall Smith |
| Correspondent | C. Marshall Smith PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,, KS 66215 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1994-07-13 |