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What standard exactly, for a stethoscope? I know nothing of this, but it looks like stethoscopes are Class 1 medical devices with 501(k) exemption, and fall un
by nomel 6mo ago
What standard exactly, for a stethoscope?
I know nothing of this, but it looks like stethoscopes are Class 1 medical devices with 501(k) exemption, and fall under the "Good manufacturing practices" guidelines of Quality System Regulation (21 CFR 820), but that seems pretty squishy.
- conception 6mo agoCFR 21 being labeled squishy is a first for me.
- nomel 6mo agoCFR 21 is the whole thing. I'm specifically referring to Part 820, within the context of a stethoscope.
- conception 6mo agoFair