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U.S. Department of Health and Human Services

Product Classification

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Device legging, compression, non-inflatable
Regulation Description Carbon dioxide gas analyzer.
Regulation Medical Specialty Anesthesiology
Review Panel Cardiovascular
Product CodeLLK
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Circulatory Support Devices Branch (CSDB)
Submission Type 510(k)
Regulation Number 868.1400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible