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U.S. Department of Health and Human Services

Product Classification

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Device analyzer, oxyhemoglobin concentration, blood-phase, indwelling
Regulation Description Indwelling blood oxyhemoglobin concentration analyzer.
Definition A pma or notice of completion of a pdp is required to be filed with the food and drug administration on or before september 21, 2004, for any indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before may 28, 1976, or that has, on or before september 21, 2004, been found to be substantially equivalent to an indwelling blood oxyhemoglobin concentration analyzer that was in commercial distribution before may 28, 1976.Any other indwelling blood oxyhemoglobin concentration analyzer shall have an approved pma or declared completed pdp in effect before being placed in commercial distribution.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeJED
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type PMA
Regulation Number 868.1120
Device Class 3
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
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