Simplifying Global Compliance
Hitachi Medical Systems America, Inc. - August 4, 2009
Your firm's "in-house" oasis model MRI laser product lacks: a 21DFR Subchapter J ratification label; a class II non-interlocked protective housing label; a class II laser warning log type which conforms to either 21 CFR 1040.10 or to IEC 60825.
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