510(k) K093192
K093192 is an FDA 510(k) premarket notification submitted by Advanced Vascular Dynamics for the device "FLOCHEC PHOTO PLETHYSMOGRAPHIC DEVICE". The FDA issued a decision of Substantially Equivalent on February 12, 2010. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Advanced Vascular Dynamics has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2010
- Date Received
- October 9, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device Class
- Class II
- Regulation Number
- 870.2780
- Review Panel
- CV
- Submission Type