§898.12. Performance standard. — Inbound Citations
21 C.F.R. § 898.12
Statutory Authority
Cited by 3 regulations in release Current.
Citations to 21 C.F.R. § 898.12 as a whole
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(e) For electrode lead wires and patient cables intended for use with a medical device, an Affirmation of Compliance with the applicable performance standard under § 898.12 of this chapter.
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Electrode lead wires and patient cables intended for use with a medical device shall be subject to the performance standard set forth in § 898.12.
Citations to §898.12(a)
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The dates for compliance with the standard set forth in § 898.12(a) shall be as follows: