The following data is part of a premarket notification filed by International Biomedical, Ltd. with the FDA for Aeronox Nitric Oxide Titration & Monitoring System.
| Device ID | K093260 |
| 510k Number | K093260 |
| Device Name: | AERONOX NITRIC OXIDE TITRATION & MONITORING SYSTEM |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. Austin, TX 78754 |
| Contact | Amy Pieper |
| Correspondent | Amy Pieper INTERNATIONAL BIOMEDICAL, LTD. 8508 CROSS PARK DR. 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 | 2009-10-19 |
| Decision Date | 2009-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868406000068 | K093260 | 000 |