510(k) K896034
K896034 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM". The FDA issued a decision of Substantially Equivalent on January 18, 1990. The device falls under product code DSB (Plethysmograph, Impedance), a Class II device regulated under 21 CFR 870.2770. D. E. Hokanson, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1990
- Date Received
- October 16, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2770
- Review Panel
- CV
- Submission Type