The following data is part of a premarket notification filed by Fadasis Medical, Inc. with the FDA for Fadassi Medical Fm-1 No Blender.
| Device ID | K003665 |
| 510k Number | K003665 |
| Device Name: | FADASSI MEDICAL FM-1 NO BLENDER |
| Classification | Apparatus, Nitric Oxide, Backup Delivery |
| Applicant | FADASIS MEDICAL, INC. 7601-B MURPHY DR. Middletown, WI 53562 |
| Contact | Raymond Riddle |
| Correspondent | Raymond Riddle FADASIS MEDICAL, INC. 7601-B MURPHY DR. Middletown, WI 53562 |
| Product Code | MRO |
| CFR Regulation Number | 868.5165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-28 |
| Decision Date | 2001-02-23 |