510(k) K023707
K023707 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "A16 BLOOD FLOW MEASUREMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 2003. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 2003
- Date Received
- November 4, 2002
- Clearance Type
- Special
- 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