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510(k) K896345

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

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

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  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K911143 — PB100 DIAGNOSTIC SPIROMETER (November 29, 1991)
  • K880550 — BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (July 25, 1988)