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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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.
Product CodeJED
Regulation Number 868.1120
Device Class 3

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