510(k) K982707

EC6 PLETHYSMOGRAPH by D. E. Hokanson, Inc. — Product Code JOM

K982707 is an FDA 510(k) premarket notification submitted by D. E. Hokanson, Inc. for the device "EC6 PLETHYSMOGRAPH". The FDA issued a decision of Substantially Equivalent on August 26, 1998. 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
August 26, 1998
Date Received
August 3, 1998
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