Oscar II Capnometer & Pulse Oximeter

No FDA recalls on record, checked 22 Oct 2026.

Full name

Oscar(Tm) II Capnometer & Pulse Oximeter

510(k) Number

K904843 ↗

FDA Product Code

CBR

Device Class

Class II

Regulation

21 CFR Part 868.1700

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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• What is the OSCAR II Capnometer & Pulse Oximeter used for?

  The OSCAR II Capnometer & Pulse Oximeter is designed for monitoring respiratory and circulatory functions during anesthesia and other medical procedures. It measures carbon dioxide levels and oxygen saturation in patients.

• Is the OSCAR II Capnometer & Pulse Oximeter single-use or reusable?

  The device is not specified as single-use or reusable in the provided information. Users should consult the manufacturer's instructions for specific guidance on device reuse or disposal.

• What is the regulatory status of the OSCAR II Capnometer & Pulse Oximeter?

  The OSCAR II Capnometer & Pulse Oximeter is authorized under FDA 510K clearance with K number K904843. It is classified as a Class II medical device and is intended for use in anesthesiology settings.

• Who manufactures the OSCAR II Capnometer & Pulse Oximeter?

  The OSCAR II Capnometer & Pulse Oximeter is manufactured by Dalton Instrument Corp., located in Helsinki, Finland. The contact person is RAUNO RUOHO.