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510(k) K090722

SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM by Shape Medical Systems, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2009
Date Received
March 19, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Shape Medical Systems, Inc.

  • K150888 — Shape-HF Cardiopulmonary Testing System (January 21, 2016)

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