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510(k) K993641

METALYZER, MODEL 2; METALYZER, MODEL 3 by Cortex Biophysik GmbH — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2000
Date Received
October 28, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Cortex Biophysik GmbH

  • K001631 — CORTEX METAMAX (February 22, 2001)

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