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 |