The following data is part of a premarket notification filed by International Biomedical with the FDA for Aeronox 2.0 Nitric Oxide Titration & Monitoring System.
| Device ID | K193481 |
| 510k Number | K193481 |
| Device Name: | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper International Biomedical 8206 Cross Park Drive Austin, TX 78754 |
| Product Code | MRN |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-17 |
| Decision Date | 2020-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865648000337 | K193481 | 000 |