510(k) K011874
- Device
- FADASIS MEDICAL FM-1 NO BLENDER
- Applicant
- Fadasis Medical, Inc.
- 510(k) number
- K011874
- Product code
- MRO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-20
- Date received
- 2001-06-15
- Regulation
- 868.5165
- Classification name
- Apparatus, Nitric Oxide, Backup Delivery
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- RAYMOND RIDDLE
- Address
- 7601-B Murphy Dr. Middleton WI US 53562 53562
FDA Registration Numbers#
- 3012796317
- 2518435
- 3019771924
- 3014527933
- 3004531588
- 1625392