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Parker Quality & Compliance

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Device type

Embryo Image Assessment System, Assisted Reproduction

Product code PBH · Class II · 21 CFR 884.6195 · Obstetrics/Gynecology

The device will obtain and analyze light microscopy images of developing embryos. This device provides information to aid in the selection of embryo(s) for transfer when there are multiple embryos deemed suitable for transfer or freezing .

FDA classification database

Recent 510(k)s

Recent recalls

No recalls in the archive for PBH.