510(k) K851633

CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL by Eaton Medical Group — Product Code DPS

K851633 is an FDA 510(k) premarket notification submitted by Eaton Medical Group for the device "CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL". The FDA issued a decision of Substantially Equivalent on June 26, 1985. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Eaton Medical Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1985
Date Received
April 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type