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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tympanometer, exempt
Regulation Description Auditory impedance tester.
Definition This product code is the class II exempt counterpart of NAS, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 874.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTP
Regulation Number 874.1090
Device Class 2

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