Product code MLC— Cardiovascular
DATASCOPE 6000 MONITOR
- Classification name
- Monitor, St Segment
- Device class
- Class 2
- Regulation
- 21 CFR 870.2340
- Advisory panel
- Cardiovascular
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code MLC
FDA has cleared devices under product code MLC between 1993 and 2000, 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
- 2000
- 1993
Top applicants under product code MLC
Recent clearances under product code MLC
Data sourced from openFDA. This site is unofficial and independent of the FDA.