CFR
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870.3670—Pacemaker charger.
(a) Identification.
A pacemaker charger is a device used transcutaneously to recharge the batteries of a rechargeable pacemaker.
(b) Classification.
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Code of Federal Regulations
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