The following data is part of a premarket notification filed by Pulmonox Medical Corp. with the FDA for Aeronox Universal, Model P/n 360000, Aeronox Bedside, Model P/n 360001, Aeronox Transport Transport, Model P/n 360002.
| Device ID | K000653 |
| 510k Number | K000653 |
| Device Name: | AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002 |
| Classification | Apparatus, Nitric Oxide Delivery |
| Applicant | PULMONOX MEDICAL CORP. 5243-53 AVE. Tofield, Alberta, CA T0b 4j0 |
| Contact | Paula Tomat |
| Correspondent | Paula Tomat PULMONOX MEDICAL CORP. 5243-53 AVE. Tofield, Alberta, CA T0b 4j0 |
| Product Code | MRN |
| Subsequent Product Code | MRO |
| Subsequent Product Code | MRP |
| Subsequent Product Code | MRQ |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-28 |
| Decision Date | 2000-08-04 |