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510(k) K974200

ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM by Orca Diagnostics Corp. — Product Code BZM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1998
Date Received
November 10, 1997
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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  • K911143 — PB100 DIAGNOSTIC SPIROMETER (November 29, 1991)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)
  • K880550 — BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS (July 25, 1988)