Oxi Temp

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K963496 ↗

FDA Product Code

DQA

Device Class

Class II

Regulation

21 CFR Part 870.2700

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Capnocheck II, Model 8400

  Class II

  FDA 510(k) K991086 Active Cleared 9 Jun 1999

• NEWOX2

  Class II

  FDA 510(k) K945754 Active Cleared 17 Jul 1995

• Autocorr Plus; 3404 Oximeter/ECG Monitor

  Class II

  FDA 510(k) K981939 Active Cleared 20 Aug 1998

• Pulse Oximeter

  Class II

  FDA 510(k) K941289 Active Cleared 22 Jun 1994

• 3301T Oxitemp

  Class II

  FDA 510(k) K946185 Active Cleared 17 Mar 1995

• BCI 3401 Handheld Pulse Oximeter

  Class II

  FDA 510(k) K980714 Active Cleared 25 Mar 1998

See all devices from Bci Intl., Inc. →