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 |