The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Ventilator, Non-continuous (respirator).
| Device ID | K201439 |
| 510k Number | K201439 |
| Device Name: | Ventilator, Non-continuous (Respirator) |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Contact | Jennifer Richardson |
| Correspondent | Jennifer Richardson Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668 |
| Product Code | BZD |
| Subsequent Product Code | CAW |
| Subsequent Product Code | CBK |
| Subsequent Product Code | MNR |
| Subsequent Product Code | MNS |
| Subsequent Product Code | MNT |
| Subsequent Product Code | NOU |
| Subsequent Product Code | OLZ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-09-25 |