Puritan Bennett™ 560 Ventilator

The Puritan Bennett™ 560 ventilator system has not been FDA cleared. The Puritan Bennett™ 560 ventilator system has been authorized by FDA under an EUA. The Puritan Bennett™ 560 ventilator system is authorized only for the duration of the declaration that circumstances exist justifying the authorization of emergency use of this ventilator system under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.