Product code MRO— Anesthesiology
FADASIS MEDICAL FM-1 NO BLENDER
- Classification name
- Apparatus, Nitric Oxide, Backup Delivery
- Device class
- Class 2
- Regulation
- 21 CFR 868.5165
- Advisory panel
- Anesthesiology
- Total cleared
- 4
- First cleared
- Most recent
Market context for product code MRO
FDA has cleared devices under product code MRO between 2001 and 2012, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2012
- 2005
- 2001
Top applicants under product code MRO
Recent clearances under product code MRO
Data sourced from openFDA. This site is unofficial and independent of the FDA.