The following data is part of a premarket notification filed by Parker Hannifin with the FDA for Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50.
| Device ID | K202480 |
| 510k Number | K202480 |
| Device Name: | Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | Parker Hannifin 245 Township Line Road Hatfield, PA 19440 |
| Contact | Andrew Ellinger |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-08-28 |
| Decision Date | 2021-04-22 |