510(k) K883908
K883908 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "3D VASCULAR RECORDER". The FDA issued a decision of Substantially Equivalent on October 28, 1988. 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
- October 28, 1988
- Date Received
- September 15, 1988
- 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