The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda Inovent Delivery System.
Device ID | K000186 |
510k Number | K000186 |
Device Name: | DATEX-OHMEDA INOVENT DELIVERY SYSTEM |
Classification | Apparatus, Nitric Oxide Delivery |
Applicant | DATEX-OHMEDA PO BOX 7550 Madison, WI 53707 |
Contact | Daniel Kosednar |
Correspondent | Daniel Kosednar DATEX-OHMEDA PO BOX 7550 Madison, WI 53707 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-14 |
Decision Date | 2000-02-10 |