510(k) K896345

EXERCISE EVALUATION SYSTEM 2010 by Medical Graphics Corp. — Product Code BZM

K896345 is an FDA 510(k) premarket notification submitted by Medical Graphics Corp. for the device "EXERCISE EVALUATION SYSTEM 2010". The FDA issued a decision of Substantially Equivalent on January 20, 1990. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900. Medical Graphics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1990
Date Received
November 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type