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U.S. Department of Health and Human Services

Product Classification

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Device compressor, cardiac, external
Regulation Description External cardiac compressor.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeDRM
Premarket Review Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Prostheses (DHT2B)
Submission Type 510(k)
Regulation Number 870.5200
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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